Effect of an individualized versus standard pneumoperitoneum pressure strategy on postoperative recovery: a randomized clinical trial in laparoscopic colorectal surgery.

BACKGROUND: It remains uncertain whether individualization of pneumoperitoneum pressures during laparoscopic surgery improves postoperative recovery. This study compared an individualized pneumoperitoneum pressure (IPP) strategy with a standard pneumoperitoneum pressure (SPP) strategy with respect to postoperative recovery after laparoscopic colorectal surgery. METHODS: This was a multicentre RCT. The IPP strategy comprised modified patient positioning, deep neuromuscular blockade, and abdominal wall prestretching targeting the lowest intra-abdominal pressure (IAP) that maintained acceptable workspace. The SPP strategy comprised patient positioning according to the surgeon's preference, moderate neuromuscular blockade and a fixed IAP of 12 mmHg. The primary endpoint was physiological postoperative recovery, assessed by means of the Postoperative Quality of Recovery Scale. Secondary endpoints included recovery in other domains and overall recovery, the occurrence of intraoperative and postoperative complications, duration of hospital stay, and plasma markers of inflammation up to postoperative day 3. RESULTS: Of 166 patients, 85 received an IPP strategy and 81 an SPP strategy. The IPP strategy was associated with a higher probability of physiological recovery (odds ratio (OR) 2·77, 95 per cent c.i. 1·19 to 6·40, P = 0·017; risk ratio (RR) 1·82, 1·79 to 1·87, P = 0·049). The IPP strategy was also associated with a higher probability of emotional (P = 0·013) and overall (P = 0·011) recovery. Intraoperative adverse events were less frequent with the IPP strategy (P < 0·001) and the plasma neutrophil-lymphocyte ratio was lower (P = 0·029). Other endpoints were not affected. CONCLUSION: In this cohort of patients undergoing laparoscopic colorectal surgery, an IPP strategy was associated with faster recovery, fewer intraoperative complications and less inflammation than an SPP strategy. Registration number: NCT02773173 ( http://www.clinicaltrials.gov).

ANTECEDENTES: No se sabe con certeza si individualizar las presiones del neumoperitoneo durante la cirugía laparoscópica mejora la recuperación postoperatoria. Comparamos una estrategia con individualización de la presión del neumoperitoneo (individualised pneumoperitoneum pressure, IPP) frente a una estrategia con presión estándar del neumoperitoneo (standard pneumoperitoneum pressure, SPP) respecto a la recuperación postoperatoria tras cirugía colorrectal laparoscópica. MÉTODOS: Ensayo clínico aleatorizado multicéntrico. La estrategia IPP consistió en una modificación de la posición, bloqueo neuromuscular profundo, y una distensión de la pared abdominal conseguida con la presión intraabdominal (intra-abdominal pressure, IAP) más baja en la que el espacio quirúrgico operativo siguiera siendo aceptable. La estrategia SPP consistió en una posición de acuerdo con la preferencia del cirujano, bloqueo neuromuscular moderado, e IAP fija de 12 mm Hg. El resultado primario fue la recuperación fisiológica postoperatoria, evaluada mediante la escala de calidad en la recuperación postoperatoria (Postoperative Quality of Recovery Scale, PQRS). Los resultados secundarios incluyeron la recuperación en otros dominios y la recuperación global, la aparición de complicaciones intraoperatorias y postoperatorias, duración de la estancia hospitalaria, y los valores de los marcadores inflamatorios séricos durante tres días postoperatorios. RESULTADOS: De un total de 166 pacientes, 85 recibieron una estrategia IPP y 81 una estrategia SPP. La estrategia IPP se asoció con una elevada probabilidad de recuperación fisiológica (razón de oportunidades, odds ratio OR, 2,8 (i.c. del 95% 1,2-6,4); P = 0,017, razón de riesgo, 1,8 (i.c. del 95% 1,7-1,9), P = 0,05)). La estrategia IPP también se asoció con una elevada probabilidad de recuperación emotiva (P = 0,013) y global (P = 0,011). Los eventos adversos intraoperatorios fueron menos frecuentes con la estrategia IPP (P < 0,001) y la tasa neutrófilo-linfocito fue más baja (P = 0,029). No se observaron cambios en otras variables. CONCLUSIÓN: En esta cohorte de pacientes sometidos a cirugía colorrectal laparoscópica, una estrategia IPP se asoció con una recuperación más rápida, menos complicaciones intraoperatorias y menos inflamación en comparación con una estrategia SPP.

The fragility of statistically significant findings in randomised controlled anaesthesiology trials: systematic review of the medical literature.

The fragility index (FI), the number of events the statistical significance a result depends on, and the number of patients lost to follow-up are important parameters for interpreting randomised clinical trial results. We evaluated these two parameters in randomised controlled trials in anaesthesiology. For this, we performed a systematic search of the medical literature, seeking articles reporting on anaesthesiology trials with a statistically significant difference in the primary outcome and published in the top five general medicine journals, or the top 15 anaesthesiology journals. We restricted the analysis to trials reporting clinically important primary outcome measures. The search identified 139 articles, 35 published in general medicine journals and 104 in anaesthesiology journals. The median (inter-quartile range) sample size was 150 (70-300) patients. The FI was 4 (2-17) and 3 (2-7), and the number of patients lost to follow-up was 0 (0-18) and 0 (0-6) patients in trials published in general medicine and anaesthesiology journals, respectively. The number of patients lost to follow-up exceeded the FI in 41 and 27% in trials in general medicine journals and anaesthesiology journals, respectively. The FI positively correlated with sample size and number of primary outcome events, and negatively correlated with the reported P-values. The results of this systematic review suggest that statistically significant differences in randomised controlled anaesthesiology trials are regularly fragile, implying that the primary outcome status of patients lost to follow-up could possibly have changed the reported effect.

SARS-CoV-2 infection. Descriptive analysis of a selected case series.

OBJECTIVES: COVID-19 was declared pandemic by March 2020. Clinical, analytical, and radiological findings have been reported. Detailed different evolution of patients of the same local outbreak has been scarcely reported. We report 6 selected cases of such an evolution. CLINICAL CASES: The clinical, radiological, analytical evolution of 6 patients is reported. Patients were selected as it were epidemiological close contacts, and showed particular different clinical evolution. RESULTS: The clinical course at the start of infection (first week) was similar among patients. In relationship with clinical evolution, middle to severe course were related with inflammation markers levels evolution (D-dimer, IL-6, ferritin, lymphocytes count, etc.). Specially lung alterations were observed, but neurological/neuropsychiatric findings are still common. In evolution, 2 patients showed middle symptoms, but the 2 most severely affected died. CONCLUSIONS: It remains to be elucidated the different evolutive pathways and outcomes of COVD-19. In our 6 patients of the same local outbreak, clinical, laboratory and radiological features were different. We discuss some aspects of the pathophysiology of the disease, other than the widely described of the respiratory system.

[SARS-CoV-2 infection. Descriptive analysis of a selected case series]. / Infección por SARS-CoV-2. Análisis descriptivo de una serie de casos seleccionada.

OBJECTIVES: COVID-19 was declared pandemic by March 2020. Clinical, analytical, and radiological findings have been reported. Detailed different evolution of patients of the same local outbreak has been scarcely reported. We report 6 selected cases of such an evolution. CLINICAL CASES: The clinical, radiological, analytical evolution of 6 patients is reported. Patients were selected as it were epidemiological close contacts, and showed particular different clinical evolution. RESULTS: The clinical course at the start of infection (first week) was similar among patients. In relationship with clinical evolution, middle to severe course were related with inflammation markers levels evolution (D-dimer, IL-6, ferritin, lymphocytes count, etc.). Specially lung alterations were observed, but neurological/neuropsychiatric findings are still common. In evolution, 2 patients showed middle symptoms, but the 2 most severely affected died. CONCLUSIONS: It remains to be elucidated the different evolutive pathways and outcomes of COVD-19. In our 6 patients of the same local outbreak, clinical, laboratory and radiological features were different. We discuss some aspects of the pathophysiology of the disease, other than the widely described of the respiratory system.

Ultrasound observation of tissue fluid infiltration causing stridor in a woman undergoing shoulder arthroscopy.

Respiratory stridor developed rapidly during an interscalene brachial plexus block for shoulder arthroscopy in an obese woman. Extensive cervicothoracic edema due to tissue diffusion of the arthroscopic fluid was suspected. The outcome of patient after conservative management was satisfactory. We give a brief review of how this complication develops, the ultrasound findings, and briefly discuss similar cases.

[Ultrasound-guided interscalene block in a patient with supraclavicular anatomical abnormalities due to radiotherapy and surgery]. / Bloqueo interescalénico guiado por ecografía en un paciente con alteraciones anatómicas de la región supraclavicular secundarias a radioterapia y cirugía.

Regional blocks can be difficult in surgical patients with certain superficial anatomical abnormalities. Such blocks may be possible, however, under ultrasound guidance. We report a case in which a man with a fractured right humerus required an ultrasound-guided interscalene brachial plexus block. Secondary to radiotherapy, the patient had right cervical and facial abnormalities that had altered the location of external anatomical landmarks. We describe the approach used to insert the catheter and the exploration of the region by ultrasound. Nerve stimulation was not used to avoid painful contractions. Analgesia was excellent during surgery and over the following 24 hours.

[Sugammadex, efficacious in reversing a neuromuscular block in a woman with Becker muscular dystrophy]. / Eficacia de sugammadex para la reversión del bloqueo neuromuscular en una paciente con distrofia muscular de Becker.

Becker muscular dystrophy affects mainly the musculoskeletal system, causing muscle wasting and progressive weakness. A 61-year-old woman with breast cancer, who had been diagnosed with Becker muscular dystrophy 45 years earlier, was scheduled for right mastectomy. We induced general anesthesia with propofol, fentanyl, and a nondepolarizing muscle blocker (rocuronium). Neuromuscular function was monitored continuously by acceleromyographic train-of-four ratio (TOFr) (Watch-SX monitor). The block was reversed with sugammadex. After preoxygenation with fentanyl and propofol, the device was calibrated and the baseline TOFr was recorded. We injected 1 mg/kg of rocuronium and assessed TOF responses every 15 seconds. The maximum decrease in TOF response (to 0 twitches) was at 52 seconds. Tracheal intubation was uneventful. Anesthesia was maintained by intravenous infusion. The operation lasted 74 minutes. The second TOF twitch (T2) reappeared 86 minutes after the initial dose. After we injected 2 mg/kg of sugammadex, a TOFr of 0.7 was reached at 79 seconds; a TOFr of 0.9 was reached at 108 seconds and a TOFr of 1.0 at 152 seconds. No electrocardiographic or hemodynamic abnormalities occurred during sugammadex administration and there were no signs of residual neuromuscular blockade on awakening or adverse events in the following 24 hours.

[Prophylaxis for hypotension during cesarean section under spinal anesthesia: a randomized trial comparing hydroxyethyl starch 130/0.4 to ephedrine]. / Prevención de la hipotensión arterial en cesáreas con anestesia subaracnoidea. Estudio prospectivo, aleatorizado comparativo entre hidroxietilalmidón 130/0,4 y efedrina.

BACKGROUND AND OBJECTIVE: Spinal anesthesia is the technique of choice for scheduled or emergency cesarean section, but the prevalence of hypotension is high in this setting. Our aim was to compare the efficacy of a colloid (6% hydroxyethyl starch [HES] 130/0.4) to ephedrine for preventing hypotension. PATIENTS AND METHODS: Patients undergoing elective or emergency cesarean section (in non-life-threatening situations) were enrolled. Patients were randomized to 3 groups for prophylaxis. The first ephedrine group received 5 mg of ephedrine intravenously (EPHE-5); the second ephedrine group received 10 mg of the drug intravenously (EPHE-10); and the HES group received 500 mL of HES 130/0.4 in rapid infusion n 15 minutes. We recorded systolic and diastolic blood pressures and heart rate after 10 minutes in the operating room and 2, 5, 10, 15, 20, and 30 minutes after injection of the anesthetic. We also assessed the sensory and motor blockades on both sides 2, 5, 10, 15, 20, and 30 minutes after injection. Neonatal status was assessed by Apgar score and umbilical cord blood gas analysis. RESULTS: Ninety-six patients, 33 in each ephedrine group and 30 in the HES group, were enrolled. Blood pressure decreased similarly in all 3 groups (36% EPHE-5 group, 36% EPHE-10 group and 40% HES group); no significant between-group differences were observed. Nor were there significant differences in the percentages of patients requiring bolus doses of ephedrine to treat hypotension (23% in the HES group vs 33% in the EPHE-5 group and 27% in the EPHE-10 group) or in the cumulative doses of ephedrine. Neonatal status was also similarly satisfactory in all 3 groups. CONCLUSIONS: HES 130/0.4 is as useful for hypotension prophylaxis as 5-mg or 10-mg intravenous doses of ephedrine. HES 130/0.4 might be a substitute for sympathomimetic agents if adverse effects are predicted or contraindications to the use of such drugs are present.

SARS-CoV-2 infection. Descriptive analysis of a selected case series. / Infección por SARS-CoV-2. Análisis descriptivo de una serie de casos seleccionada.

OBJECTIVES: COVID-19 was declared pandemic by March 2020. Clinical, analytical, and radiological findings have been reported. Detailed different evolution of patients of the same local outbreak has been scarcely reported. We report 6 selected cases of such an evolution. CLINICAL CASES: The clinical, radiological, analytical evolution of 6patients is reported. Patients were selected as it were epidemiological close contacts, and showed particular different clinical evolution. RESULTS: The clinical course at the start of infection (first week) was similar among patients. In relationship with clinical evolution, middle to severe course were related with inflammation markers levels evolution (D-dimer, IL-6, ferritin, lymphocytes count, etc.). Specially lung alterations were observed, but neurological/neuropsychiatric findings are still common. In evolution, 2patients showed middle symptoms, but the 2most severely affected died. CONCLUSIONS: It remains to be elucidated the different evolutive pathways and outcomes of COVD-19. In our 6patients of the same local outbreak, clinical, laboratory and radiological features were different. We discuss some aspects of the pathophysiology of the disease, other than the widely described of the respiratory system.

[Low-dose hypobaric spinal anesthesia for anorectal surgery in jackknife position: levobupivacaine-fentanyl compared to lidocaine-fentanyl]. / Anestesia subaracnoidea hipobárica a dosis bajas para cirugía anorrectal en posición de navaja: comparación entre levobupivacaína-fentanilo y lidocaína-fentanilo.

OBJECTIVE: To compare the percentage of patients who were able to bypass the postoperative intensive care recovery unit after selective spinal anesthesia with lidocaine-fentanyl versus levobupivacaine-fentanyl for anorectal surgery in jackknife position. MATERIAL AND METHODS: Randomized double-blind clinical trial comparing 2 groups of 30 patients classified ASA 1-2. One group received 18 mg of 0.6% lidocaine plus 10 microg of fentanyl while the other group received 3 mg of 0.1% levobupivacaine plus 10 microg of fentanyl. Intraoperative variables were time of start of surgery, maximum extension of sensory blockade, requirement for rescue analgesics, and hemodynamic events. The level of sensory blockade was recorded at 5, 10, and 15 minutes after the start of surgery and at the end of the procedure. The degrees of postoperative motor blockade and proprioception were recorded, as were the results of the Romberg test and whether or not the patient was able to bypass the postoperative recovery unit. Also noted were times of start of ambulation and discharge, complications, and postoperative satisfaction. RESULTS: Intraoperative variables did not differ significantly between groups, and all patients in both groups bypassed the postoperative recovery unit. Times until walking and discharge home, complications, and overall satisfaction after surgery were similar in the 2 groups. CONCLUSIONS: Both spinal anesthetic solutions provide effective, selective anesthesia and are associated with similar rates of recovery care unit bypass after anorectal surgery in jackknife position.

Correction to: An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study.

After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.

An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study.

BACKGROUND: A recent study shows that a multifaceted strategy using an individualised intra-abdominal pressure titration strategy during colorectal laparoscopic surgery results in an acceptable workspace at low intra-abdominal pressure in most patients. The multifaceted strategy, focused on lower to individualised intra-abdominal pressures, includes prestretching the abdominal wall during initial insufflation, deep neuromuscular blockade, low tidal volume ventilation settings and a modified lithotomy position. The study presented here tests the hypothesis that this strategy improves outcomes of patients scheduled for colorectal laparoscopic surgery. METHODS: The Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery versus Standard Therapy (IPPCollapse-II) study is a multicentre, two-arm, parallel-group, single-blinded randomised 1:1 clinical study that runs in four academic hospitals in Spain. Patients scheduled for colorectal laparoscopic surgery with American Society of Anesthesiologists classification I to III who are aged > 18 years and are without cognitive deficits are randomised to an individualised pneumoperitoneum pressure strategy (the intervention group) or to a conventional pneumoperitoneum pressure strategy (the control group). The primary outcome is recovery assessed with the Post-operative Quality of Recovery Scale (PQRS) at postoperative day 1. Secondary outcomes include PQRS score in the post anaesthesia care unit and at postoperative day 3, postoperative complications until postoperative day 28, hospital length of stay and process-related outcomes. DISCUSSION: The IPPCollapse-II study will be the first randomised clinical study that assesses the impact of an individualised pneumoperitoneum pressure strategy focused on working with the lowest intra-abdominal pressure during colorectal laparoscopic surgery on relevant patient-centred outcomes. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance for optimising the care and safety of laparoscopic abdominal surgery. Selection of patient-reported outcomes as the primary outcome of this study facilitates the translation into clinical practice. Access to source data will be made available through anonymised datasets upon request and after agreement of the Steering Committee of the IPPCollapse-II study. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02773173 . Registered on 16 May 2016. EudraCT, 2016-001693-15. Registered on 8 August 2016.

Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients.

BACKGROUND: We have prospectively evaluated the incidence and characteristics of awareness with recall (AWR) during general anaesthesia in a tertiary care hospital. METHODS: This study involves a prospective observational investigation of AWR in patients undergoing general anaesthesia. Blinded structured interviews were conducted in the postanaesthesia care unit, on postoperative day 7 and day 30. Definition of AWR was 'when the patient stated or remembered that he or she had been awake at a time when consciousness was not intended'. Patient characteristics, perioperative, and drug-related factors were investigated. Patients were classified as not awake during surgery, AWR, AWR-possible, AWR-not evaluable. The perceived quality of the awareness episode, intraoperative dreaming, and sequelae were investigated. The anaesthetic records were reviewed to search for data that might explain the awareness episode. RESULTS: The study included 4001 patients. Incidence of AWR was 1.0% (39/3921 patients). If high risk for AWR patients were excluded, the incidence was 0.8%. After the interview on the seventh day, six patients denied having been conscious during anaesthesia; hence, the incidence of AWR in elective surgery was 0.6%. Factors associated with AWR were: anaesthetic technique incidence of 1.1% TIVA-propofol vs 0.59% balanced anaesthesia vs 5.0% O2/N2O-based anaesthesia vs 0.9% other anaesthetic techniques (mainly propofol boluses for short procedures), P=0.008; age (AWR 42.3 yr old vs 50.6 yr old, P=0.041), absence of i.v. benzodiazepine premedication (P=0.001), Caesarean section (C-section) (P=0.019), and surgery performed at night (P=0.013). More than 50% of patients reported intraoperative dreaming in the early interview, mainly pleasant. Avoidable human factors were detected from the anaesthetic records of most patients. Subjective auditory perceptions prevailed, together with trying to move or communicate, and touch or pain perception. CONCLUSIONS: A relatively high incidence of AWR and dreams during general anaesthesia was found. Techniques without halogenated drugs showed more patients. The use of benzodiazepine premedication was associated with a lower incidence of AWR. Age, C-section with general anaesthesia, and surgery performed at night are risk factors.

[Discrepancy between clinical and radiologic manifestations of an epidural hematoma after catheterization]. / Discordancia clínico-radiológica y resolución espontánea de un hematoma postcateterización epidural.

Neuraxial techniques are considered safe if certain guidelines are followed, but they are not risk free. We report the case of an 81-year-old woman with an invasive bladder tumor who underwent radical cystectomy with a Bricker-type procedure. General anesthesia was used and epidural analgesia was also provided for surgical and postoperative pain management. Late in the postoperative recovery period a large epidural hematoma was diagnosed based on radiologic signs of spinal cord compression, in the absence of symptoms other than mild and progressive back pain that developed after extubation. The surgeon decided against emergency surgery to reduce compression. Symptoms resolved gradually, and a magnetic resonance image 45 days after discharge confirmed that the hematoma was smaller. In addition to the usual safety recommendations for epidural anesthesia with regard to drugs that alter hemostasis, it is important to bear in mind circumstances that have pharmacokinetic repercussions and that increase risk. Lower back pain can be a warning sign. Some cases may resolve spontaneously.

[Anesthesia in a patient with Angelman syndrome]. / Anestesia en un caso de síndrome de Angelman.

We describe the perioperative treatment of a patient diagnosed with Angelman syndrome, which is usually caused by a deletion in chromosome 15. The patient showed the characteristic signs of psychomotor retardation, epilepsy, lack of speech, frequent laughter and happy demeanor, light skin, blue eyes, and blond hair, hyperactivity, and sleep disturbance. He was scheduled for multiple tooth extractions under general anesthesia. Intravenous anesthesia was induced using ketamine, propofol, and rocuronium, and was maintained with low concentrations of sevoflurane. There were no incidents during or after surgery. The chromosomal abnormality that causes Angelman syndrome is located on the same genes that control the production of gamma-aminobutyric acid-A receptors, which are activated by most intravenous and inhaled anesthetic agents. The effect of the condition on the response of these agents is unknown. The combined use of propofol, ketamine, and sevoflurane at low doses provided adequate anesthesia for this patient. Other characteristics of the syndrome that may affect the use of anesthesia in these patients are discussed.