Efficacy of intranasal ketamine and midazolam for pediatric sedation: A double-blind, randomized clinical trial.

BACKGROUND: Pediatric patients feel significant fear and anxiety when undergoing surgeries. The ideal drug and its administration route have not been found yet. The aim of this study was to compare the efficacy and safety of intranasal (IN) ketamine and midazolam as premedication in children. METHODS: We studied 71 eligible pediatric patients undergoing elective urologic surgeries, aged 2 to 6 years. The degree of sedation and separation scores was compared between the two groups. Additionally, hemodynamic parameters, before premedication, after induction of anesthesia, and during surgery were documented and compared between two groups. Postoperatively, any side effect was recorded as well. RESULTS: Finally, the data from 71 children were analyzed. Recovery time was significantly longer in group K (ketamine) compared to group M (midazolam); 27.86±4.42 vs 38.19± 6.67 minutes respectively (P=0.01). No significant difference was observed in terms of sedation score between two groups of K & M; 3.29±0.78 vs 3 ±0.71 respectively (P=0.17), and not regarding separation score; 2.51±0.61 & 2.31±0.52 respectively (P=0.01). Vital signs were kept within the physiological limits in both groups with no marked fluctuations. CONCLUSION: To produce sedation in young children, both midazolam and ketamine were effective and safe by IN route.

Breaking Bad News: A Valid Concern among Clinicians.

Objective: Delivering bad news is the duty of specialist physicians. However, they find it very difficult due to insufficient experience. In this study, the way faculty and residents of Guilan University of Medical Sciences (GUMS) delivered bad news to the patients was investigated. Method : This study was conducted at hospitals affiliated to GUMS during 2017. A questionnaire containing 18 items on environmental and psychical support was filled through a face to face interview. The first 10 questions evaluated psychical support and the next eight environmental supports. The scoring of each question ranged from 10 to 50, with 10 indicating "never" and 50 "always". Results: According to the analysis of 235 questionnaires, only 32 (13.6%) of the participants had been taught to deliver bad news and 195(83%) felt they need educational courses. Also, 40 (17%) believed that they had enough ability to deliver these massages. No significant differences were observed among physicians who had taken teaching courses in breaking bad news to patients. Conclusion: This study revealed that educational courses to improve physicians' communication skill to break bad news to patients are strongly warranted.

Right ventricular dysfunction and associated factors in patients after coronary artery bypass grafting.

BACKGROUND: Coronary artery bypass grafting (CABG) surgery is widely accepted as a revascularization method for coronary artery disease (CAD). Despite survival benefit and improvement in quality of life, CABG may impose major morbidities and significant complications. Right ventricle (RV) dysfunction is an important complication that may affect patient's longevity and functional capacity. The aim of this study was to evaluate the relationship between RV dysfunction and some invisible parameters like inferior vena cava (IVC) size with physical capacity. METHODS: In this prospective study, 61 eligible CABG candidates were enrolled and RV function was assessed by echocardiographic parameters before CABG and one week and six months after the procedure, using tricuspid annular plane systolic excursion (TAPSE), Tei Index (TI), peak systolic movement (Sm) (cm/s), and IVC size. Functional capacity was assessed by six-minute walk test (6-MWT) 6 months after CABG. RESULTS: 58 patients who did not have any perioperative RV dysfunction were remained until the end of study; mean age was 58.2 ± 7.9 years with 68.9% being men, and 3 patients died after CABG. Preoperatively, septal motion, RV indices, and IVC size were normal in all patients. The frequency of RV dysfunction according to abnormal TAPSE index, TI, and peak Sm one week after surgery was 81.0%, 79.0%, and 62.0%, respectively, and 6 months after surgery was 49.0%, 49.0%, and 37.0%, respectively. Mean walked distance in 6-MWT was significantly less in patients with RV dysfunction, older age, and higher number of involved vessels (P < 0.001). CONCLUSION: The significant reduction in RV function and impairment of exercise capacity after CABG in this study suggests cardiologists to pay more attention to RV assessment in follow-up visits of patients undergoing GABG.

Hemodynamic parameters and reproductive outcome after intracytoplasmic sperm injection and fresh embryo transfer in patients undergoing oocyte retrieval with general anesthesia using fentanyl, remifentanil or alfentanil - A randomized clinical trial.

OBJECTIVE: Anesthesia for assisted reproductive technology is very important to provide less stressful and painful environment for patients, with minimal side effects on oocytes. In the present study, we aimed to evaluate hemodynamic parameters, recovery time and intracytoplasmic sperm injection (ICSI) outcome among patients underwent anesthesia with fentanyl, remifentanil or alfentanil. MATERIAL AND METHODS: This randomized double-blinded clinical trial was conducted in patients undergoing anesthesia for transvaginal ultrasound guided oocyte retrieval (TUGOR). Patients were randomly allocated to alfentanil (A; 15 µg/kg), fentanyl (F; 1.5 µg/kg) or remifentanil (R; 1.5 µg/kg) groups. RESULTS: Three hundred forty patients were assessed for eligibility and randomized for transvaginal oocyte retrieval following general anesthesia and 105 were lost to follow up. No statistically significant differences were noted among groups regarding basic characteristics. Although, time to respond to verbal command was significantly different among groups (A: 1.99 ± 1.64, F: 2.56 ± 1.72, R: 1.78 ± 1.34, P = 0.014). There were no significant differences among groups with respect to the first and second postoperative pain intensity, patient satisfaction, pre-induction and post-induction systolic and diastolic blood pressure (BP). Terminal systolic (A: 101.61 ± 9.15, F: 105.29 ± 12.61, R: 102 ± 12.91, P = 0.01) and diastolic (A: 59.97 ± 9, F: 65.63 ± 9.13, R: 63.69 ± 11.01, P = 0.003) BP was significantly different among groups. The fertilization rate was significantly different among groups (A: 51.6%, F: 54.4%, R: 62.2%, P = 0.018). Implantation rate, biochemical and clinical pregnancy rate was similar among groups. CONCLUSIONS: The results of present study demonstrated that all three opioids have the same efficiency, in regards to patient satisfaction and pregnancy outcome. However, Anesthesia with alfentanil compared with fentanyl and remifentanil, seems to be inferior for TUGOR due to higher effect on fertilization rate and less hemodynamic stability. REGISTRATION NUMBER: IRCT201410258677N4.

Evaluation of Admission Indications, Clinical Characteristics and Outcomes of Obstetric Patients Admitted to the Intensive Care Unit of a Teaching Hospital Center: A Five-Year Retrospective Review.

BACKGROUND: Care of obstetric patients has always been a challenge for critical care physicians, because in addition to their complex pregnancy-related disease, fetal viability is considered. OBJECTIVES: The aim of this study was to review the admission indications, clinical characteristics and outcomes of obstetric patients, admitted to the intensive care unit of Alzzahra teaching hospital affiliated to Guilan University of Medical Sciences, Rasht, Iran. METHODS: This retrospective cohort study was conducted on pregnant /post-partum (up to 6 weeks) patients admitted to the ICU over a 5-year period from April 2009 to April, 2014. RESULTS: Data from 1019 subjects were analyzed. Overall, 90.1% of the patients were admitted in the postpartum period. The most common indications for admission were pregnancy related hypertensive disorders (27.5%) and obstetric hemorrhage (13.5%). Epilepsy (5.4%) and cardiac disease (5.2%) were the most common non-obstetric indications. CONCLUSIONS: Pregnancy-related hypertensive disorders and obstetric hemorrhage were the main reasons for admission, and epilepsy and cardiac disease were the most common non-obstetric indications. Efforts must be concentrated on increasing antenatal care.

Effect of Selenium on Stress Response in Coronary Artery Bypass Graft Surgery: A Clinical Trial.

BACKGROUND: In spite of significant improvements in surgical and anesthetic techniques, acute stress response to surgery remains a main cause of mortality and morbidity in coronary artery bypass graft (CABG) surgery patients. Therefore, doing research to find safe and effective modalities with more cardio protective properties seems necessary. OBJECTIVES: In this study, we sought to determine whether intravenous injection of 600 µg Selenium (Se) prior to surgery would limit stress response measured by blood sugar. METHODS: This double blind clinical trial was conducted at a referral center of cardiac surgery affiliated to Guilan University of Medical Sciences (GUMS) from June 2015 to October 2015. 73 eligible patients candidate for elective isolated CABG surgery were enrolled in the trial. They were randomly allocated to either Se group (n = 36) receiving 600 µg Se prior to surgery or control group (n = 37). Our evaluation was based on blood sugar (BS) which was measured at four point times, including before induction of anesthesia (T0), at the end of CPB (T1), 24 hours (T2) and 48 hours (T3) after surgery. RESULTS: The data obtained from 73 patients in group S (n = 36) and group C (n = 37) were analyzed. There was no significant difference between the two groups regarding the baseline characteristics. In both groups, a sharp rise in BS levels was observed following CPB (P = 0.0001). Although the trend of BS changes was remarkable in both groups (P = 0.0001), there was no statistically significant difference between the groups at all point times including T0 (P = 0.45), T1 (P = 0.48), T2 (P = 0.92), and T3 (P = 0.42). Within the study time, our patients were monitored for any adverse effect but nothing was observed. CONCLUSIONS: This investigation showed that intravenous single dose of 600 µg Se was safe in CABG patients, but had no positive effect on stress response to surgery.

Comparing the Effect of Adding Fentanyl, Sufentanil, and Placebo with Intrathecal Bupivacaine on Duration of Analgesia and Complications of Spinal Anesthesia in Patients Undergoing Cesarean Section.

BACKGROUND: Spinal anesthesia is the method of choice for most elective and emergency Cesarean sections. To increase the duration of anesthesia and improve the quality of analgesia during and after surgery, intrathecal opioids, as adjuvant drugs, are used in combination with local anesthetics. METHODS: This was a double-blind clinical trial performed on 99 patients. Women were divided into 3 groups of fentanyl, sufentanil, and placebo. For fentanyl group, 12.5 mg of bupivacaine and 25 micrograms of fentanyl; for sufentanil group, 12.5 mg of bupivacaine and 2.5 micrograms of sufentanil; and for placebo group, 12.5 mg of bupivacaine and a half mL of normal saline were injected in subarachnoid space. The sensory and motor block, hemodynamic status (mean blood pressure and heart rate), and probable complications were assessed. RESULTS: There was no significant difference between the groups in demographic characteristics. Durations of analgesia were, respectively, 314 ± 42.95, 312.5 ± 34.44, and 116.1 ± 42.24 minutes in the fentanyl, sufentanil, and placebo groups (P = 0.0001). Duration of sensory and motor block was higher in fentanyl and sufentanil groups compared with the placebo group. The highest duration of sensory and motor block was noted in sufentanil group (P = 0.0001). No significant difference was found between the groups in the hemodynamic parameters (P > 0.05). The frequency of itching in the fentanyl group was higher than sufentanil and placebo groups (P = 0.003). Also, shivering was higher in the placebo group compared with other groups (P = 0.036). CONCLUSIONS: According to the results, adding 25 microgram fentanyl or 2.5 microgram sufentanil to intrathecal bupivacaine increased the duration of analgesia and provided hemodynamic stability with no major complication. As administering intrathecal fentanyl had a similar duration of analgesia like sufentanil with faster return of motor block and ambulation, it seems that it is a preferred additive for Cesarean section surgery.

Comparing the Effectiveness of Patient Control Analgesia Pump and Bolus Morphine in Controlling Pain After Cardiopulmonary Bypass Graft Surgery.

BACKGROUND: Postoperative pain is a complex process commonly caused by surgical trauma. It is one of the major concerns of patients undergoing heart surgery. Despite new techniques and modern analgesic treatments, postoperative pain is still one of the most important controversial issues. METHODS: 68 patients scheduled for elective CABG with CPB were included in a prospective, double-blind clinical trial. They were randomly divided into two groups. One group received PCA pump including morphine (group P) with underlying infusion of 0.02 mg/kg/Qh, bolus dose of 1 mg, lockout time of 15 minutes, and a maximum of 4 bolus of 0.02 mg/kg for one hour and the other group received morphine bolus (group B). Three patients were excluded from the study, and 33 and 32 patients participated in the groups P and B, respectively. Variables including age, gender, pump time, aortic clamp time, duration of surgery, complications (nausea and vomiting, GI Bleeding, and hypoxia), level of pain based on VAS, opioid consumption, hemodynamic, and sedation status were measured in both groups. RESULTS: There was no significant difference between the groups regarding age, gender, pump time, clamp time, duration of surgery, complication, sedation score, and hemodynamic status in most of the assessment periods. By assessing the pain severity in the groups at different periods, results showed a significant difference between the groups except at enrollment, and a lower severity of pain was noted in the group P compared to the group B. The consumed opioid was significantly higher in the group P than in the group B. However, higher doses of diclofenac and paracetamol were administered in the group B compared to the group P. CONCLUSIONS: Results showed that higher morphine would be used in patients with PCA pump after extubation following heart surgery, and this increased dose of opioid was associated with better pain control and lack of complication. Therefore, PCA pump with underlying infusion could be effectively used in patients undergoing CABG that are directly assessed in intensive care unite.

Effects of Low-dose Selenium on the Inflammatory Response in Coronary Artery Bypass Graft Surgery: A Clinical Trial.

BACKGROUND: Coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB) triggers an inflammatory reaction, leading to the development of myocardial damage and dysfunction. It is suggested that selenium (Se), an essential trace element, has a protective role against oxidative stress. Decreased intraoperative Se levels might be an independent predictive factor for postoperative multiorgan failure. In spite of its proposed advantages, however, the optimal timing and dosage are not well known. OBJECTIVES: To determine whether 600 µg of intravenous Se administration before induction of anesthesia for CABG surgery could attenuate inflammatory reactions in an Iranian population. METHODS: This randomized triple-blind clinical trial took place in the department of cardiac surgery of an academic hospital affiliated with Guilan University of Medical Sciences (GUMS) from May 2015 to September 2015. Eighty-eight eligible patients scheduled for elective on-pump CABG surgery were divided into two groups using randomized fixed quadripartite blocks. They received either an intravenous bolus of 600 µg Se before induction of anesthesia, or normal saline as a placebo. We had four measurement time-points: just before induction of anesthesia (T0), immediately after the end of CPB (T1), 24 hours after surgery (T2), and 48 hours after surgery (T3). Interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), and C-reactive protein (CRP) serum levels were measured using the enzyme-linked immunosorbent assay (ELISA). RESULTS: Data from a total of 81 patients were analyzed: group S (n = 41) and group C (n = 40). There was no significant difference between the two groups with regard to baseline characteristics. In both groups, CPB caused markedly increased IL-6, TNF-α, and CRP plasma concentrations compared with baseline (P = 0.0001). However, the pattern of changes was not significantly different between group S (P = 0.068) and group C (P = 0.26). The IL-6 and TNF-α change trends were significant in each group (P=0.0001). However, comparing the two groups showed no significant difference. With regard to IL-6, there was no significant difference between the two groups at the time-points of T1 (P = 0.34), T2 (P = 0.17), and T3 (P = 0.056), and the same was found for TNF-α at T1 (P = 0.34), T2 (P = 0.17), and T3 (P = 0.056). With regard to CRP, the trend of the changes was significant in each group (P = 0.0001). However, comparing two groups showed a borderline significant difference between them at T1 (P = 0.039), but not at T2 (P = 0.075) or T3 (P = 0.11). CONCLUSIONS: This study revealed that the administration of 600 µg of intravenous Se immediately before induction of anesthesia was safe, but when compared to a placebo, no predominant clinical effects or modifications in the systemic inflammatory response induced by on-pump CABG were observed.

Postoperative Pain After Abdominal Hysterectomy: A Randomized, Double-Blind, Controlled Trial Comparing the Effects of Tramadol and Gabapentin as Premedication.

BACKGROUND: Uncontrolled postoperative pain, characteristic to abdominal hysterectomy, results in multiple complications. One of the methods for controlling postoperative pain is preemptive analgesia. Gabapentin and tramadol are both used for this purpose. OBJECTIVES: This study aims to compare the effects of tramadol and gabapentin, as premedication, in decreasing the pain after hysterectomy. PATIENTS AND METHODS: This clinical trial was performed on 120 eligible elective abdominal hysterectomy patients, divided in three groups of 40, receiving tramadol, gabapentin and placebo, respectively. Two hours before the surgery, the first group was given 300 mg gabapentin, the second one was given 100 mg tramadol, while the other group was given placebo, with 50 ml water. After the surgery, in case of visual analog pain scale (VAS) > 3, up to 3 mg of diclofenac suppository would be used. Pain score, nausea, vomiting, sedation, patient's satisfaction and the number of meperidine administered during 24 hours (1 - 4 - 8 - 12 - 16 - 20 - 24 hours) were recorded. If patients had VAS > 3, despite using diclofenac, intravenous meperidine (0.25 mg/kg) would be prescribed. Data were analyzed using SPSS 21 software, chi-square test, general linear model and repeated measurement. RESULTS: The three groups were similar regarding age and length of surgery (up to 2 hours). The average VAS, in the placebo group, was higher than in the other two groups (P = 0.0001) and the average received doses of meperidine during 24-hour time were considerably higher in placebo group, compared to the other two groups (55.62 mg in placebo, 18.75 mg in gabapentin and 17.5 mg in tramadol groups, P = 0.0001). Nausea, vomiting and sedation, in the tramadol group, were higher than in the other two groups, although they were not significant. Patients' dissatisfaction, in the placebo group, during initial hours, especially in the fourth hour, was higher (P = 0.0001). In the gabapentin and tramadol groups, the trend of changes in satisfaction score was similar. However, satisfaction in the gabapentin group, during the initial 4 hours was higher, in comparison to the tramadol group (P = 0.0001). CONCLUSIONS: This study revealed that prescribing gabapentin or tramadol, as premedication, was effective in reducing postoperative pain, without any concerning side-effects.