Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S).

BACKGROUND: efficacy of therapeutic cholecalciferol supplementation for severe COVID-19 is sparingly studied. OBJECTIVE: effect of single high-dose cholecalciferol supplementation on sequential organ failure assessment (SOFA) score in moderate-to-severe COVID-19. METHODS: participants with moderate to severe COVID-19 with PaO2/FiO2 ratio < 200 were randomized to 0.6 million IU cholecalciferol oral (intervention) or placebo. OUTCOMES: primary outcome was change in Day 7 SOFA score and pre-specified secondary outcomes were SOFA and 28-day all-cause mortality. RESULTS: in all, 90 patients (45 each group) were included for intention-to-treat analysis. 25(OH)D3 levels were 12 (10-16) and 13 (12-18) ng/ml (P = 0.06) at baseline; and 60 (55-65) ng/ml and 4 (1-7) ng/ml by Day 7 in vitamin D and placebo groups, respectively. The SOFA score on Day 7 was better in the vitamin D group [3 (95% CI, 2-5) versus 5 (95% CI, 3-7), P = 0.01, intergroup difference - 2 (95% CI, -4 to -0.01); r = 0.4]. A lower all-cause 28-day mortality [24% compared to 44% (P = 0.046)] was observed with vitamin D. CONCLUSIONS: single high-dose oral cholecalciferol supplementation on ICU admission can improve SOFA score at Day 7 and reduce in-hospital mortality in vitamin D-deficient COVID-19. ClinicalTrials.gov  id: NCT04952857 registered dated 7 July 2021. What is already known on this topic-vitamin D has immunomodulatory role. Observational and isolated intervention studies show some benefit in COVID-19. Targeted therapeutic vitamin D supplementation improve outcomes in severe COVID-19 is not studied in RCTs. What this study adds-high-dose vitamin D supplementation (0.6 Million IU) to increase 25(OH)D > 50 ng/ml is safe and reduces sequential organ failure assessment score, in-hospital mortality in moderate to severe COVID-19. How this study might affect research, practice or policy-vitamin D supplementation in vitamin D-deficient patients with severe COVID-19 is useful may be practiced.

Comparison of midpoint transverse process to pleura (MTP) block and erector spinae plane block (ESP) for postoperative analgesia in modified radical mastectomy patients: A double-blinded, randomized control trial.

Background and Aims: Modified radical mastectomy (MRM) is associated with moderate severity of postoperative pain. Besides intravenous (IV) analgesics, various nerve blocks are being described for pain relief of MRM patients. We compared erector spinae plane (ESP) block with midpoint transverse process to pleura (MTP) block in these patients for postoperative analgesia. Material and Methods: After receiving ethical committee approval from the institutional ethics committee (AIIMS, Jodhpur) and written informed consent from study participants, 66 patients who were assigned American Society of Anesthesiologists (ASA) physical status I and II, aged 18-75 years, and were scheduled to undergo MRM were enrolled and randomly allocated into two groups. Unilateral block was given before surgery at T3 or T4 level and with 15 ml of 0.5% ropivacaine in both the groups. Infusion of 0.5% ropivacaine (Neon laboratories limited, Mumbai, India) and 0.2% ropivacaine at a rate of 5 ml/h was maintained intraoperatively and postoperatively, respectively. Pain was assessed using the Visual Analogue Scale (VAS) for the next 24 hours. The total number of patients needing rescue analgesia, the total amount of rescue analgesics consumed in the next 24 hours, and patient satisfaction score were also compared between groups. Results: Demographics and baseline vitals were comparable in the groups. On comparing VAS scores in both the groups during rest and movement at different time intervals, there was no difference in pain scores during the initial two hours. From the third hour, there was a statistically significant difference (P < 0.001) in pain VAS scores in both groups. The ESP group had lower VAS scores compared to the MTP group when followed for the next 24 hours. There was a statistically significant difference in patient satisfaction. Conclusion: ESP block is more efficacious when compared to MTP block for postoperative analgesia in MRM patients.

Transurethral lidocaine (100 mg) bladder irrigation (TULI100) reduces the incidence of catheter related bladder discomfort in transurethral resection of bladder tumors: A randomized, double blind, controlled trial.

BACKGROUND: Transurethral resection of bladder tumors (TURBT) surgeries requires post-resection catheterization for continuous irrigation of the bladder. This indwelling catheter is associated with distressing catheter-related bladder discomfort (CRBD) and increases postoperative pain and agitation. OBJECTIVES: To prove the hypothesis that transurethral 100 mg lidocaine irrigation at the end of TURBT can reduce the frequency of moderate-to-severe postoperative CRBD. METHODS: 116 patients scheduled for TURBT were screened, 94 were recruited and completed the study. American Society of Anesthesiologists Physical Status I-II adult patients, 20-75 years of age undergoing elective TURBT surgery under general anesthesia were included. Transurethral normal saline with 0.01% lidocaine (100 mg in 1 L NS) was used for irrigation 30 min before the completion of surgery in group L, while only normal saline was used for transurethral irrigation in group N. The main outcomes were frequency of CRBD, pain and patient satisfaction at 0, 1, 2, and 6 h postoperatively. RESULTS: A total of 94 patients were analyzed in the study. The incidence of moderate-severe CRBD was significantly lower in group L as compared to group C at 0, 1, and 2 h (65.9% vs. 31.9%, p = 0.01; 31.9% vs. 10.6%, p = 0.012; 21.3% vs. 2.1%, p = 0.004, respectively). At the 6-h mark, the incidence of CRBD was lower in group L, although this did not achieve statistical significance (6.38% vs. 2.1%; p = 0.613). CONCLUSION: Irrigation with 0.01% lidocaine (100 mg) towards the end of TURBT reduces the incidence of moderate-severe CRBD by 52% and increases patient satisfaction.

Incidence & outcomes of clinically significant bleeding events in critically ill COVID-19 patients receiving Therapeutic dose AntiCoagulanTs: A retrospective cohort study (INTerACT study).

Background & objectives: The high mortality associated with the thrombotic events in hospitalized COVID-19 patients resulted in the usage of anticoagulants in varying doses. Whether high-dose anticoagulants have led to better outcomes or higher incidence of clinically significant bleeding events is debatable. Thus, this study was conducted to find the incidence of clinically significant bleeding events in moderate-to-severe COVID-19 ARDS (acute respiratory distress syndrome) patients on therapeutic anticoagulation and their outcomes. Methods: In this retrospective, single-centre study of 155 critically ill COVID-19 patients, the incidence of clinically significant bleeding was observed. Multivariate regression models were used to evaluate the association between anticoagulant regimen, coagulation and inflammatory markers with the incidence of bleeding and thrombotic events. Results: The incidence of clinically relevant non-major bleeding was 33.54 per cent (26.17-41.46%) and major bleeding was 9.03 per cent (5.02-14.69%). The anticoagulation intensity at baseline had a high odds of major bleeding when enoxaparin and dual antiplatelet therapy were used together [adjusted odds ratio OR of 434.09 (3.81-49502.95), P<0.05]. At admission, bleeders had a poorer PaO2/FiO2 ratio with more patients on invasive ventilation. At the time of bleeding, the bleeders had a higher D-dimer, ferritin, C-reactive protein and procalcitonin compared to non-bleeders. The subhazard ratio for death in bleeders was 3.35 (95% confidence interval, 1.97-5.65; P<0.001). Interpretation & conclusions: The incidence of bleeding in critically ill COVID-19 patients on therapeutic anticoagulation may increase with the severity of the disease as well as with concurrent use of dual antiplatelets. Major bleeding may also contribute to higher mortality.

Comparison of the effects of opioid-free anesthesia (OFA) and opioid-based anesthesia (OBA) on postoperative analgesia and intraoperative hemodynamics in patients undergoing spine surgery: A prospective randomized double-blind controlled trial.

Background: Opioids form the basis of perioperative pain management but are associated with multiple side effects. In opioid-free anesthesia (OFA), several non-opioid drugs or neuraxial/regional blocks are used as substitutes for opioids. Ketamine, a N-methyl-d-aspartate antagonist, provides intense analgesia. However, there is a shortage of literature on the effects of ketamine-based OFA on hemodynamics (HD) and postoperative analgesia in patients undergoing thoracolumbar spine surgery. Materials and Methods: This prospective randomized controlled trial included 60 adult patients. The patients in Group OFA (n = 30) received OFA with ketamine and ketofol (1:5) infusion, and those in Group OBA (n = 30) received opioid-based anesthesia (OBA) with fentanyl and propofol infusion. The postoperative pain-free period, pain scores, rescue analgesia, intraoperative HDs, and postoperative complications were assessed. Results: The mean pain-free period in Group OFA (9.86 ± 1.43 hr) was significantly higher than that in Group OBA (6.93 ± 1.93 hr) (P = 0.002). During the postoperative 48 hours, the total requirement of fentanyl was considerably lower in Group OFA (P < 0.05). There was a significantly higher incidence of hypertension in Group OFA (46%) and hypotension (43%) in Group OBA (43%), respectively. Postoperative nausea vomiting (PONV) was more common in Group OBA at the 2nd and 6th hr (P = 0.046 and P = 0.038). Conclusion: OFA with ketamine and ketofol provided adequate postoperative analgesia with a lower incidence of PONV after spine surgery. However, hypertension in the ketamine group and hypotension in the propofol group required fine titration of the infusion rate of drugs during the intraoperative period.

Hyperosmolar Therapy in Elderly Neurosurgical Patients: Comparison of the Effect of Mannitol (20%) and Hypertonic Saline (3%) on Advanced Cardiovascular Parameters Using Transesophageal Echocardiography: A Preliminary Randomized Controlled Trial.

OBJECTIVE: Osmotherapeutic agents increase the intravascular volume by withdrawing water from the brain followed by relative hypovolemia due to diuresis leading to significant changes in systemic hemodynamics which might have adverse consequences in the elderly. We studied the effect of mannitol (20%) and hypertonic saline (HTS) (3%) on left ventricular outflow tract velocity time integral (LVOT-VTI) and cardiac output (CO) in elderly patients undergoing supratentorial neurosurgical procedures using transesophageal echocardiography. METHODS: We recruited 28 patients aged above 65 years undergoing supratentorial craniotomy who received equiosmolar solutions of 5.35 ml/kg of 3% HTS (group HS, n = 14) or 5 ml/kg of 20% mannitol (group M, n = 14). LVOT-VTI was recorded at baseline, 15, 30, 45, 60, and 90 minutes postinfusion and CO was derived. We also recorded heart rate, blood pressure, fluid balance, brain relaxation, vasopressor use, complications, and neurological outcome. RESULTS: We found a significant decrease in LVOT-VTI at 45, and 60 minutes in group M as compared to group HS [mean (standard deviation), 16.76 (1.81) vs. 20.78 (1.87), P < 0.001, 17.4 (2.38) vs. 19.16 (2), P = 0.044, respectively]. We also found a corresponding significant fall in CO [3863.16 (845.87) vs. 4745.59 (1209.33) ml/minute, P = 0.034] and systolic blood pressure (P = 0.039), at 45 minutes in group M. Urine output was higher in group M (P < 0.001). All other parameters were comparable. CONCLUSIONS: HTS appears to be associated with better systemic hemodynamics (LVOT-VTI, CO) while providing equivalent brain relaxation as mannitol in elderly patients. A future larger study is required to confirm our preliminary findings.

Effect of Fluid Therapy on Acid-Base Balance in Patients Undergoing Clipping for Ruptured Intracranial Aneurysm: A Prospective Randomized Controlled Trial.

Objectives Neurosurgical patients often receive 0.9% normal saline (NS) during the perioperative period. Theoretically, a balanced salt solution (BSS) is better than 0.9% saline. We compared the effects of two different fluids on acid-base balance, renal function, and neurological outcome in patients who underwent clipping following subarachnoid hemorrhage from a ruptured intracranial aneurysm. Materials and Methods Patients in group NS ( n = 30) received 0.9% saline and group BSS ( N = 30) received BSS (Plasmalyte-A) in the perioperative period for 48 hours. Comparison of arterial pH, bicarbonate, and base deficit measured preoperatively, intraoperatively (first and second hour), and postoperatively (at 24 and 48 hours) was the primary outcome of the study. The secondary outcome compared serum electrolytes, renal function tests, urine neutrophil gelatinase-associated lipocalin (NGAL), serum cystatin C, and the neurological outcome using modified Rankin score (MRS) at discharge, 1, and 3 months. Results In group NS, significantly low pH at 1-hour intraoperative period was seen compared with group BSS (7.37 ± 0.06 vs. 7.40 ± 0.05, p = 0.024). The bicarbonate level in group NS was significantly lower and the base deficit was higher at second intraoperative hour (bicarbonate: 17.49 vs. 21.99 mEq/L, p = 0.001; base deficit: 6.41 mmol/L vs. 1.89 mmol/L, p = 0.003) and at 24 hours post-surgery (bicarbonate: 20.38 vs. 21.96 mEq/L, p = 0.012; base deficit: 3.56 mmol/L vs. 2.12 mmol/L, p = 0.034)). Serum creatinine was higher in group NS at 24 hours (0.66 vs. 0.52 mg/dL, p = 0.013) and 48 hours (0.62 vs. 0.53 mg/dL, p = 0.047). Serum urea, electrolytes, cystatin, urine NGAL, and MRS were comparable. Conclusion In neurosurgical patients undergoing clipping for ruptured intracranial aneurysm, using a BSS during the perioperative period is associated with a better acid-base and renal profile. However, the biomarkers of kidney injury and long-term outcomes were comparable.

Effect of Peri-operative Blood Transfusion on Neurological Outcome Following Aneurysmal Subarachnoid Hemorrhage: A Prospective Observational Study.

BACKGROUND: Anemia is a common complication of aneurysmal subarachnoid hemorrhage and is associated with unfavorable outcomes. Whether the physiological benefits of transfusion for anemia surpass the risk of blood transfusion remains to be determined. OBJECTIVES: The primary outcome was to evaluate the impact of peri-operative blood transfusion on the long-term neurological outcome, assessed by Glasgow Outcome Scale Extended at 3 months. The secondary outcomes included the impact of transfusion on the short-term neurological outcome, assessed by Modified Rankin Score at discharge/7 days, and on the incidence of vasospasm, infarction, re-exploration, tracheostomy, and length of hospital stay. MATERIAL AND METHODS: This prospective observational study was conducted on 185 patients with aneurysmal subarachnoid hemorrhage undergoing clipping of the aneurysmal neck. In our study, blood transfusion was administered to keep the target Hb around 10 g/dL. RESULTS: Unfavorable long-term outcome was found in 27/97 (28%) of patients who received a blood transfusion as compared to 13/74 (18%) of patients who did not receive a transfusion (P = 0.116). Patients receiving transfusion had more chances of an unfavorable outcome at discharge/7 days as compared to those not transfused [44/103 (43%) versus 22/80 (27%)], P = 0.025. There were increased chances of vasospasm, infarction, re-exploration, tracheostomy, and increased length of hospital stay in patients receiving transfusion (P < 0.05). CONCLUSIONS: The use of blood transfusion in patients with aneurysmal subarachnoid hemorrhage was associated with increased neurological complications and hence an unfavorable short-term outcome. However, when used judiciously as per the clinical requirements, blood transfusion did not have a significant effect on long-term neurological outcome.

Utility of the Awake Video Laryngoscopy Assisted Fibreoptic Intubation Technique in Maxillofacial Gunshot Injury - A Case Report.

Rationale: Maxillofacial gunshot injury leads to significant soft tissue and bone defects, which compromise airway patency, thus posing a challenge for the anaesthesiologist. The utility of the videolaryngoscopy-assisted fibreoptic intubation (VAFI) technique in maxillofacial gunshot injury has not yet been described in the literature. Patient Concerns: We report the case of a young male presenting with extensive maxillofacial wounds with fractures of the bilateral maxilla, mandible and floor of orbit secondary to self-inflicted gunshot injury. Diagnosis: Major peri-operative concerns included anticipated difficult airway, control of potential haemorrhage and airway oedema. Treatment: A flexible fibreoptic bronchoscope used in combination with a video laryngoscope was used to successfully secure the airway. Outcome: He was extubated on the same day and discharged after two weeks. Take-Away Lessons: The current case highlights the safe and effective use of the videolaryngoscopy-assisted fibreoptic intubation technique in maxillofacial gunshot injury.

Comparison of Midazolam and Propofol Infusion to Suppress Stress Response in Patients With Severe Traumatic Brain Injury: A Prospective, Randomized Controlled Trial.

Objective: The stress response following traumatic brain injury (TBI) is a preventable cause of secondary brain injury. This can be prevented using sedation in the intensive care unit (ICU). To date, the choice of sedative agent for preventing stress response is not well-studied in literature. Methods: This prospective randomized controlled trial included 60 patients with severe TBI admitted to ICU. The patients were randomized into 2 study groups according to the choice of sedation: propofol (group I) and midazolam infusion (group II). The serum cortisol was measured as the primary outcome at admission to ICU and 48 hours following sedation infusion. The baseline Glasgow coma scale, hemodynamic, optic nerve sheath diameter (ONSD), and computed tomography scan findings were noted at admission. Glasgow outcome scale (GOS) was measured as a neurological outcome at discharge from ICU. Results: There was a statistically significant reduction in serum cortisol level in both the study groups (Δ cortisol, p-value=134.91 (50.5,208.2), 0.00 and 118.8 (42.6,160.4), 0.00, in group I and II, respectively). Serum cortisol levels were comparable among both groups at baseline and 48 hours. Similarly, there was a statistically significant difference in ONSD in both groups, but there was no difference in ONSD value between the groups at 48 hours. The GOS was also similar in both groups at discharge from ICU. Conclusion: The study demonstrated a similar reduction in serum cortisol levels following 48 hours of propofol or midazolam infusion in patients with severe TBI.

Preoperative assessment of inferior vena cava collapsibility index by ultrasound is not a reliable predictor of post-spinal anesthesia hypotension.

BACKGROUND: Post-spinal anesthesia hypotension is of common occurrence, and it hampers tissue perfusion. Several preoperative factors determine patient susceptibility to hypotension. This study aimed to assess the effectiveness of the Inferior Vena Cava Collapsibility Index (IVCCI) for predicting intraoperative hypotension. METHODS: One hundred twenty-nine adult patients who were scheduled for elective surgical procedures after administration of spinal (intrathecal) anesthesia were included in the study. Ultrasound evaluation of the Inferior Vena Cava (IVC) was done in the preoperative area, and the patients were shifted to the Operating Room (OR) for spinal anesthesia. An independent observer recorded the change in blood pressure after spinal anesthesia inside the OR. RESULTS: Twenty-five patients developed hypotension (19.37%). Baseline systolic blood pressure and mean blood pressures were statistically higher in those patients who developed hypotension (p = 0.001). The logistic regression analysis for IVCCI and the incidence of hypotension showed r2 of 0.025. Receiver Operating Characteristic (ROC) curve analysis demonstrated the Area Under the Curve (AUC) of 0.467 (95% Confidence Interval, 0.338 to 0.597; p = 0.615). CONCLUSIONS: Preoperative evaluation of IVCCI is not a good predictor for the occurrence of hypotension after spinal anesthesia.

Assessment of impaired cerebral autoregulation and its correlation with neurological outcome in aneurysmal subarachnoid hemorrhage: A prospective and observational study.

Background: Cerebral autoregulation (CA) is crucial for the maintenance of cerebral homeostasis. It can be assessed by measuring transient hyperemic response ratio (THRR) using transcranial Doppler (TCD). We aimed at assessing the incidence of impaired CA (ICA) and its correlation with the neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Methods: One hundred consecutive patients with aSAH scheduled for aneurysmal clipping were enrolled in this prospective and observational study. Preoperative and consecutive 5-day postoperative THRR measurements were taken. Primary objective of the study was to detect the incidence of ICA and its correlation with vasospasm (VS) postclipping, and neurological outcome at discharge and 1, 3, and 12 months was secondary objectives. Results: ICA (THRR < 1.09) was observed in 69 patients preoperatively, 74 patients on the 1st and 2nd postoperative day, 76 patients on 3rd postoperative day, and 78 patients on 4th and 5th postoperative day. Significant VS was seen in 13.4% and 61.5% of patients with intact THRR and deranged THRR, respectively (P < 0.000). Out of 78 patients who had ICA, 42 patients (53.8%) at discharge, 60 patients (76.9%) at 1 month, 54 patients (69.2%) at 3 month, and 55 patients (70.5%) at 12 months had unfavorable neurological outcome significantly more than those with preserved CA. Conclusion: Incidence of ICA assessed in aSAH patients varies from 69% to 78% in the perioperative period. The deranged CA was associated with significantly poor neurological outcome. Therefore, CA assessment using TCD-based THRR provides a simple, noninvasive bedside approach for predicting neurological outcome in aSAH.

Ketofol as an Anesthetic Agent in Patients With Isolated Moderate to Severe Traumatic Brain Injury: A Prospective, Randomized Double-blind Controlled Trial.

BACKGROUND: The effects of ketofol (propofol and ketamine admixture) on systemic hemodynamics and outcomes in patients undergoing emergency decompressive craniectomy for traumatic brain injury (TBI) are unknown and explored in this study. METHODS: Fifty patients with moderate/severe TBI were randomized to receive ketofol (n=25) or propofol (n=25) for induction and maintenance of anesthesia during TBI surgery. Intraoperative hemodynamic stability was assessed by continuous measurement of mean arterial pressure (MAP) and need for rescue interventions to maintain MAP within 20% of baseline. Brain relaxation scores, serum biomarker-glial fibrillary acidic protein levels, and extended Glasgow Outcome Scale (GOSE) at 30 and 90 days after discharge were also explored. RESULTS: MAP was lower and hemodynamic fluctuations more frequent in patients receiving propofol compared with those receiving ketofol (P<0.05). MAP fell >20% below baseline in 22 (88%) patients receiving propofol and in 10 (40%) receiving ketofol (P=0.001), with a greater requirement for vasopressors (80% vs. 24%, respectively; P=0.02). Intraoperative brain relaxation scores and GOSE at 30 and 90 day were similar between groups. Glial fibrillary acidic protein was lower in the ketofol group (3.31±0.43 ng/mL) as compared with the propofol (3.41±0.17 ng/mL; P=0.01) group on the third postoperative day. CONCLUSION: Compared with propofol, ketofol for induction and maintenance of anesthesia during decompressive surgery in patients with moderate/severe TBI was associated with improved hemodynamic stability, lower vasopressor requirement, and similar brain relaxation.

Comparison of Effects of Propofol and Sevoflurane on the Cerebral Vasculature Assessed by Digital Subtraction Angiographic Parameters in Patients Treated for Ruptured Cerebral Aneurysm: A Preliminary Study.

BACKGROUND: Studies have evaluated the effects of volatile and intravenous anesthetic agents on the cerebral vasculature with inconsistent results. We used digital subtraction angiography to compare the effects of propofol and sevoflurane on the luminal diameter of cerebral vessels and on cerebral transit time in patients with aneurysmal subarachnoid hemorrhage (aSAH). METHODS: This prospective preliminary study included adult patients with good-grade aSAH scheduled for endovascular coil embolization; patients were randomized to receive propofol or sevoflurane anesthesia during endovascular coiling. The primary outcome was the luminal diameter of 7 cerebral vessel segments measured on the diseased and nondiseased sides of the brain at 3 time points: awake, postinduction of anesthesia, and postcoiling. Cerebral transit time was also measured as a surrogate for cerebral blood flow. RESULTS: Eighteen patients were included in the analysis (9 per group). Baseline and intraoperative parameters were similar between the groups. Propofol increased the diameter of 1 vessel segment at postinduction and postcoiling on the diseased side and in 1 segment at postcoiling on the nondiseased side of the brain ( P <0.05). Sevoflurane increased vessel diameter in 3 segments at postinduction and in 2 segments at postcoiling on the diseased side, and in 4 segments at postcoiling on the nondiseased side ( P <0.05). Cerebral transit time did not change compared with baseline awake state in either group and was not different between the groups. CONCLUSIONS: Sevoflurane has cerebral vasodilating properties compared with propofol in patients with good-grade aSAH. However, sevoflurane affects cerebral transit time comparably to propofol.

To ascertain the plasma concentration of propofol to achieve bispectral index-guided sedation using a target-controlled infusion in patients undergoing elective surgeries under neuraxial anaesthesia.

Background and Aims: Sedation improves patient satisfaction, comfort and acceptance of regional anaesthesia. Propofol using bispectral index (BIS)/target-controlled infusion (TCI) system can be an optimal method of sedation, as it combines objective measurement of sedation using BIS along with maintenance of a steady plasma concentration of propofol with the TCI device. The aim of this study was to ascertain the dose and safety of propofol using BIS/TCI system for sedation in patients undergoing surgeries under neuraxial anaesthesia. Methods: One hundred and seven adult patients, undergoing elective surgical procedures under spinal or combined spinal epidural anaesthesia, were recruited. Propofol infusion was started with TCI at an initial target plasma concentration (Cpt) of 1.2 µg/mL, and after equilibration between Cpt and effect site concentration (Ce), propofol was then adjusted in increments and/or decrements of 0.2 µg/mL in order to maintain a BIS value between 60 and 80. The average time to reach BIS = 80 after starting infusion was 7.32 ± 3.13 minutes. The objective was to calculate mean Cpt value maintaining BIS between 60 and 80 and to observe recovery time and complications. Results: Mean Cpt value was 1.13 ± 0.17 mg/mL with 95% confidence interval (1.10-1.16 µg/mL). In 85% of patients, a BIS value of 60-80 was maintained at Cpt ≤ 1.2 µg/mL. No patient had severe complications requiring stoppage of infusion. Conclusion: Propofol sedation using BIS/TCI system can provide safe and convenient sedation during neuraxial anaesthesia at very low plasma concentration, Cpt ≤ 1.2 µg/mL in majority of patients. There were no periprocedural complications, and recovery was rapid.

Diclofenac Is Superior to Paracetamol in Postoperative Pain Scores and Analgesic Consumption in Supratentorial Craniotomy With No Difference in Platelet and Clot Function: A Prospective Randomized Controlled Trial.

BACKGROUND: The use of nonsteroidal anti-inflammatory drugs in neurosurgery remains controversial because of potential risk of hematoma formation secondary to platelet dysfunction. This study aimed to investigate the efficacy and safety of diclofenac compared with paracetamol for the management of postcraniotomy pain. METHODS: In all, 110 adult patients undergoing craniotomy for supratentorial tumors were randomized to receive either intravenous paracetamol (15 mg/kg) or intravenous diclofenac sodium (1.5 mg/kg) 30 minutes before the end of surgery and postoperatively at 12-hour intervals up to 48 hours. The analgesic efficacy of diclofenac and paracetamol was assessed using the Numerical Rating Scale (NRS) score at 12, 24, and 48 hours after surgery. We also examined the need for rescue analgesia, coagulation profiles using a Sonoclot analyzer, and incidence of intracranial hematoma formation. RESULTS: At 24 hours postsurgery, NRS scores were lower in group D than in group P; median (interquartile range) and mean rank NRS score in group D was 3.00 (1.0), 43.71, respectively, compared with 3.00 (1.0), 59.29 in group P (P=0.004). Patients in group P received more rescue analgesia than those in group D. Coagulation profiles were similar between groups at 24 hours. Activated clotting time was longer in group D (128.76±12.61 s) than in group P (123.84±09.77 s; P=0.03) at 48 hours, although remained within normal limits in both groups; clot rate and platelet function were similar at 48 hours. There was no difference in the incidence of postoperative tumor bed hematoma. CONCLUSION: Compared with paracetamol, diclofenac sodium provided more effective postoperative analgesia at 24 hours with no evidence of adverse effects on coagulation profiles in patients undergoing craniotomy for supratentorial tumors.

Goal-directed Fluid Therapy Versus Conventional Fluid Therapy During Craniotomy and Clipping of Cerebral Aneurysm: A Prospective Randomized Controlled Trial.

BACKGROUND: Fluid imbalance is common after aneurysmal subarachnoid hemorrhage and negatively impacts clinical outcomes. We compared intraoperative goal-directed fluid therapy (GDFT) using left ventricular outflow tract velocity time integral (LVOT-VTI) measured by transesophageal echocardiography with central venous pressure (CVP)-guided fluid therapy during aneurysm clipping in aneurysmal subarachnoid hemorrhage patients. METHODS: Fifty adults scheduled for urgent craniotomy for aneurysm clipping were randomly allocated to 2 groups: group G (n=25) received GDFT guided by LVOT-VTI and group C (n=25) received CVP-guided fluid management. The primary outcome was intraoperative mean arterial pressure (MAP). Secondary outcomes included volume of fluid administered and several other intraoperative and postoperative variables, including neurological outcome at hospital discharge and at 30 and 90 days. RESULTS: There was no difference in MAP between the 2 groups despite patients in group G receiving lower volumes of fluid compared with patients in group C (2503.6±534.3 vs. 3732.8±676.5 mL, respectively; P <0.0001). Heart rate and diastolic blood pressure were also comparable between groups, whereas systolic blood pressure was higher in group G than in group C at several intraoperative time points. Other intraoperative variables, including blood loss, urine output, and lactate levels were not different between the 2 groups. Postoperative variables, including creatinine, duration of postoperative mechanical ventilation, length of intensive care unit and hospital stay, and incidence of acute kidney injury, pneumonitis, and vasospasm were also comparable between groups. There was no difference in neurological outcome at hospital discharge (modified Rankin scale) and at 30 and 90 days (Extended Glasgow Outcome Scale) between the 2 groups. CONCLUSION: Compared with CVP-guided fluid therapy, transesophageal echocardiography-guided GDFT maintains MAP with lower volumes of intravenous fluid in patients undergoing clipping of intracranial aneurysms with no adverse impact on postoperative complications.