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Preclinical data suggest that general anaesthetics affect brain development. There is mixed evidence from cohort studies that young children exposed to anaesthesia can have an increased risk of poor neurodevelopmental outcome. We aimed to establish whether general anaesthesia in infancy has any effect on neurodevelopmental outcome. Here we report the secondary outcome of neurodevelopmental outcome at 2 years of age in the General Anaesthesia compared to Spinal anaesthesia (GAS) trial. In this international assessor-masked randomised controlled equivalence trial, we recruited infants younger than 60 weeks postmenstrual age, born at greater than 26 weeks' gestation, and who had inguinal herniorrhaphy, from 28 hospitals in Australia, Italy, the USA, the UK, Canada, the Netherlands, and New Zealand. Infants were randomly assigned (1:1) to receive either awake-regional anaesthesia or sevoflurane-based general anaesthesia. Web-based randomisation was done in blocks of two or four and stratified by site and gestational age at birth. Infants were excluded if they had existing risk factors for neurological injury. The primary outcome of the trial will be the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) Full Scale Intelligence Quotient score at age 5 years. The secondary outcome, reported here, is the composite cognitive score of the Bayley Scales of Infant and Toddler Development III, assessed at 2 years. The analysis was as per protocol adjusted for gestational age at birth. A difference in means of five points (1/3 SD) was predefined as the clinical equivalence margin. This trial is registered with ANZCTR, number ACTRN12606000441516 and ClinicalTrials.gov, number NCT00756600. Between Feb 9, 2007, and Jan 31, 2013, 363 infants were randomly assigned to receive awake-regional anaesthesia and 359 to general anaesthesia. Outcome data were available for 238 children in the awake-regional group and 294 in the general anaesthesia group. In the as-per-protocol analysis, the cognitive composite score (mean [SD]) was 98·6 (14·2) in the awake-regional group and 98·2 (14·7) in the general anaesthesia group. There was equivalence in mean between groups (awake-regional minus general anaesthesia 0·169, 95% CI −2·30 to 2·64). The median duration of anaesthesia in the general anaesthesia group was 54 min. For this secondary outcome, we found no evidence that just less than 1 h of sevoflurane anaesthesia in infancy increases the risk of adverse neurodevelopmental outcome at 2 years of age compared with awake-regional anaesthesia. Australia National Health and Medical Research Council (NHMRC), Health Technologies Assessment-National Institute for Health Research UK, National Institutes of Health, Food and Drug Administration, Australian and New Zealand College of Anaesthetists, Murdoch Childrens Research Institute, Canadian Institute of Health Research, Canadian Anesthesiologists' Society, Pfizer Canada, Italian Ministry of Heath, Fonds NutsOhra, and UK Clinical Research Network (UKCRN).

A randomized trial evaluating spinal as compared with general anesthesia for hip-fracture surgery in adults 50 years of age or older did not show superiority of spinal anesthesia with respect to a composite of death or an inability to walk unassisted at 60 days. Postoperative delirium occurred in similar percentages of patients in the two groups.

Reports have suggested the use of intravenous infusion of vasopressors as an approach to prevent spinal anesthesia-induced hypotension (SAIH) in women undergoing cesarean deliveries. However, data on the suitability of this technique for obese people are limited. As such, the current experiment was designed to clarify the dose-response relationship associated with the preventive administration of phenylephrine to avoid SAIH during cesarean delivery in obese parturients under combined spinal-epidural anesthesia. The current study included 100 parturients with a body mass index ≥30 kg/m who were undergoing cesarean section delivery. They were randomly treated with phenylephrine at different doses: 0.375, 0.5, 0.625, or 0.75 μg/kg/min. An infusion of phenylephrine was deemed beneficial if hypotension was absent, with hypotension defined as a systolic blood pressure <90 mmHg or <80% of the baseline value between spinal injection and the delivery of the newborn. The 50% and 90% effective doses (ED and ED , respectively) for prophylactic phenylephrine were determined via a probit regression. Respective rates of hypotension in the 0.375, 0.5, 0.625, and 0.75 groups were 52% (13/25), 40% (10/25), 20% (5/25), and 0% (0/25). ED and ED values of 0.42 (95% confidence interval 0.30-0.48) and 0.68 (95% confidence interval 0.60-0.87) μg/kg/min were calculated for phenylephrine treatment. The study results indicated that prophylactic phenylephrine, which prevents SAIH in obese parturients following cesarean delivery, has calculated values of 0.42 and 0.68 μg/kg/min. These findings may contribute to developing appropriate clinical practice guidelines for improved patient management. https://www.chictr.org.cn/bin/project/edit?pid=153050 . Identifier ChiCTR2200058125.

•Remimazolam significantly reduces nausea and vomiting in cesarean sections, enhancing patient satisfaction (P < 0.05).•Intravenous remimazolam administration effectively mitigates adverse reactions to carboprost tromethamine without affecting postpartum bleeding.•Study demonstrates remimazolam's potential for improving sedative outcomes in cesarean sections with CSEA anesthesia. To evaluate the effectiveness of remimazolam in preventing adverse reactions triggered by carboprost tromethamine during cesarean section procedures. A total of 200 parturients scheduled for cesarean sections at risk of postpartum hemorrhage in our hospital from October 2022 to July 2023 were included. The participants were assigned via random number table method to either a study group or a control group, resulting in 100 cases in each. All parturients received combined spinal and epidural anesthesia (CSEA) during cesarean section, followed by administration of carboprost tromethamine (250 µg) for preventing postpartum hemorrhage after childbirth. CSEA was performed with 1.8 to 2 mL of 0.5% bupivacaine and 7 to 10 mL of 2% lidocaine. The study group was given remimazolam via intravenous infusion at a rate of 0.3 mg/kg/h commencing at 1 minute prior to CSEA and concluding with a final dosage adjustment 20 minutes preceding the end of surgery, while the control group was given the same volume of saline within this time frame. Primary outcome measures were adverse reactions and sedative effects of the parturients. Nausea and vomiting were the only adverse reactions that exhibited significant differences between groups. The study group reported significantly fewer cases (32 cases) of nausea and vomiting when compared to the 48 cases observed in the control group. Moreover, the use of remimazolam appeared to alleviate the severity of nausea and vomiting, as evidenced by the significantly lower incidence of Grade III event and the higher risk of Grade I event in comparison with the control group (P < 0.05). The Apgar scores of newborns at birth and 5 minutes after birth were compared, and no statistically significant difference was found (P > 0.05). Parturients receiving remimazolam exhibited better effective sedation outcomes and were more satisfied with the treatment when compared with controls (P < 0.05). There were no significant differences in postpartum bleeding volume at 2 and 12 hours postpartum, as well as in the duration of postpartum bleeding between the two groups (P > 0.05). Intravenous administration of remimazolam effectively prevents adverse reactions induced by carboprost tromethamine during cesarean section performed under CSEA, thereby improving sedative effects.

To prospectively investigate the effect of music therapy on patient’s anxiety and pain level during retrograde intrarenal surgery under spinal anesthesia. 286 patients aged above 18 years, who underwent Retrograde Intrarenal Surgery (RIRS) under spinal anesthesia for renal or ureteral calculi were evaluated between January 2023 and June 2023 by a prospective, randomized, controlled clinical protocol. Patients were randomized into 2 groups. Group 1 included patients, who listened to music, and Group 2 was comprised of patients, who were not allowed to listen to music. Visual Analog Scale (VAS) results and pain sensation, anxiety level, together with the results of State-Trait Anxiety Inventory (STAI), a self-reported anxiety inventory, were captured. The number of patients, who were randomized to the music group (Group 1) and non-music group (Group 2) was 144 and 142, respectively. Mean heart rate in Group 1 and Group 2 was 60 ± 4.19 and 70 ± 8.36, respectively (p = 0.02), indicative of the fact that mean heart rate was significantly lower in the music group. Heart rate measured post-operatively within the first hour subsequent to the procedure was similar in both groups (p < 0.05). The VAS score was significantly lower in Group 1. STAI score in Group 1 and Group 2 was 45.51 ± 2.968 and 49.16 ± 1.88, respectively. Therefore, there was a statistically significant difference (p < 0.001). Music therapy during the RIRS procedure under spinal anesthesia was associated with a significantly decrease in pain and anxiety scores in patients.

BACKGROUND: Hip fracture surgeries in elderly patients often require spinal or general anesthesia, posing risks of severe hypotension and inadequate pain management. The optimal anesthesia type for minimizing these risks remains undetermined. Preliminary studies suggest that a combination of fascia iliaca block (FIB) and low-dose low-specific-gravity spinal anesthesia (LLSA) might offer a solution, but comprehensive evidence is lacking. OBJECTIVES: This study aimed to assess the efficacy of combining FIB with LLSA for reducing severe hypotension and enhancing analgesia during hip fracture surgery in elderly patients. STUDY DESIGN: A prospective, randomized controlled trial was conducted. SETTING: An operating theatre of a tertiary hospital. METHODS: The study comprised 68 patients. They were separated into 2 equal parallel groups 34 patients each: the FIB+LLSA group and the general anesthesia (GA) group. Patients aged 75–96 undergoing primary hip arthroplasty for hip fracture were randomized to receive either FIB+LLSA or GA. The primary outcome was the incidence of severe hypotension; secondary outcomes included postoperative pain, use of rescue analgesia, vasopressor dosage, and complications. RESULTS: We found a significantly lower incidence of severe hypotension in the FIB+LLSA group compared to the GA group (32.4% vs 67.6%). Additionally, postoperative pain scores were significantly lower, and the need for rescue analgesia was reduced in the FIB+LLSA group. Vasopressor use during surgery was also significantly lower in the FIB+LLSA group. The hospital stay was shorter in the FIB+LLSA group, with an average of 5.9 days compared to 6.7 days in the GA group. LIMITATIONS: The study’s limitations include its single-center nature, which may limit the generalizability of the findings. Additionally, the inability to conduct a double-blind study could introduce biases, though measures were taken to minimize this. The sample size might not be sufficient to determine the broader implications of LLSA. CONCLUSIONS: Combining FIB with LLSA for elderly patients undergoing hip fracture surgery significantly reduces the incidence of severe intraoperative hypotension and postoperative pain. It also decreases the need for rescue analgesia and shortens hospital stays, suggesting that FIB+LLSA could be a beneficial regional anesthesia technique for elderly hip fracture surgery patients, aligning with enhanced recovery protocols. KEY WORDS: Hip fracture, elderly, hypotension, anesthesia, fascia iliaca block, low-dose spinal anesthesia, randomized controlled trial

Background Intravenous fluid administration and prophylactic vasopressor infusion are the primary methods for preventing spinal anesthesia-induced hypotension during cesarean delivery. However, evidence regarding the impact of different volumes of crystalloid solution on the phenylephrine infusion dosage for preventing this hypotension remains inconclusive. This study aimed to determine the effect of two IV fluid infusion rates (10 or 20 mL/kg/h) on phenylephrine requirement for preventing spinal anesthesia-induced hypotension. Methods Eighty healthy parturients undergoing elective cesarean delivery under combined spinal-epidural anesthesia were enrolled. Participants were randomly assigned to receive either 10 mL/kg/h (group 10) or 20 mL/kg/h (group 20) of lactated Ringer’s solution. The first patient in each group received 0.5 µg/kg/min of phenylephrine infusion immediately after intrathecal injection. The phenylephrine dose in subsequent patients was adjusted by increments or decrements of 0.05 µg/kg/min based on the previous patient’s response. The ED50 of phenylephrine infusion for preventing spinal-induced hypotension for cesarean delivery was estimated using a modified up-down sequential analysis, with probit analysis applied as a backup sensitivity analysis. Results The ED50 values for preventing spinal anesthesia-induced hypotension were 0.30 µg/kg/min (95% CI, 0.29–0.32 µg/kg/min) for group 10, and 0.19 µg/kg/min (95% CI, 0.16–0.22 µg/kg/min) for group 20, respectively. The estimated relative potency for phenylephrine in group 10 compared to group 20 was 1.52 (95%CI, 1.24–1.97), showing a significant difference in the ED50 values between the two groups. Conclusion This study found that a higher crystalloid co-loading rate significantly reduces prophylactic phenylephrine requirement for preventing spinal anesthesia induced hypotension. Trials registration https://www.chictr.org.cn/showproj.html?proj=125918 (Trial number: ChiCTR2100048002).

Background The hemodynamic effects of relatively low-dose epinephrine and phenylephrine infusions during cesarean delivery under spinal anesthesia were compared. Methods This randomized controlled trial included full-term pregnant women who underwent elective cesarean delivery. After spinal anesthesia, participants received either epinephrine (0.03 mcg/kg/min) or phenylephrine (0.4 mcg/kg/min) infusion that continued until 5 min after delivery. The primary outcome was a composite outcome of the occurrence of any of hypotension, hypertension, bradycardia, and/or tachycardia. Neonatal outcomes, including umbilical artery blood gas and Apgar scores, were assessed. Results In total, 98 patients in each group were analyzed, and the number of patients with the composite outcome was comparable between the epinephrine and phenylephrine groups (30/98 [31%] vs. 31/98 [32%], respectively; P  = 0.877). However, the incidence of hypotension was likely lower in the epinephrine group than in the phenylephrine group ( P  = 0.066), and the number of hypotensive episodes per patient was lower in the epinephrine group than in the phenylephrine group. On the other hand, the incidence of tachycardia was higher in the epinephrine group than that in the phenylephrine group. The incidence of hypertension was comparable between the two groups and none of the participants developed bradycardia. Neonatal outcomes were comparable between the two groups. Conclusions Epinephrine and phenylephrine infusion produced comparable maternal hemodynamics and neonatal outcomes. Epinephrine was associated with a higher incidence of maternal tachycardia and likely lower incidence of maternal hypotension than phenylephrine. IRB number: MD-245–2022. Clinical trial registration: This study was registered on May 31, 2023 at clinicaltrials.gov registry, NCT05881915, URL: https://classic.clinicaltrials.gov/ct2/show/NCT05881915term=NCT05881915&draw=2&rank=1

Post dural puncture headache (PDPH) is a major challenging complication and may be a cause of morbidity after spinal anesthesia. Currently there is no definitive management for PDPH, so the search for effective treatment continues. Our aim was to investigate the analgesic effectiveness of oral prednisolone vs oral pregabalin for managing PDPH subsequent to spinal anesthesia for lower limb surgeries. A prospective controlled double-blind randomized study. Academic University Hospitals. A total of 63 patients who had lower limb surgeries and suffered PDPH after spinal anesthesia were randomly allocated into one of 3 groups. Group C patients received conservative treatment and to maintain blinding, a tablet of vitamins was given to them twice per day for 3 days; Group P patients received conservative treatment and oral prednisolone 20 mg once daily plus one tablet of vitamins (in order to ensure blinding) for 3 days; Group G patients received oral pregabalin 150 mg twice daily for 3 days in addition to conservative treatment. The primary outcomes we measured were the Visual Analog Scale (VAS) score and modified Lybecker score. The secondary outcomes we measured were the total dose of rescue analgesia, the need for an epidural blood patch (EBP), and adverse effects from the study drugs. When comparing the intensity of headaches assessed through both the VAS and the modified Lybecker score, no statistically significant disparities were observed in relation to baseline measurements. While after starting treatment by 12 hours and 24 hours, the headache intensity was statistically significantly lower in Group G compared to Group P and Group C, but there was no significant difference between Group C and Group P at 12 hours. The headache intensity was statistically significantly higher in Group C compared to Group P and Group G, but there was no significant difference between Group P and Group G at 48 hours and 72 hours. Ketorolac consumption was statistically significantly higher in group C than the other groups. However, it was statistically significantly lower in group G than group P. Only 2 patients in group C were indicated for EBP while no patients in either Groups P or G required an EBP. Our study's limitations include the paucity of literature studying prednisolone and pregabalin use in PDPH, our study's small sample size, and the lack of sufficient studies for comparing results may limit the generalization of our findings. Both oral prednisolone and pregabalin were effective in reducing PDPH severity; oral pregabalin is superior to prednisolone.

To investigate the effect of low-doses esketamine on spinal anesthesia-induced hypotension in women with preoperative anxiety undergoing elective cesarean section, the randomized controlled trial enrolled 120 women aged 18–35 years who preoperative State-Trait Anxiety Inventory State scores > 40, conducted from September 2022 to August 2023 in Xuzhou Central Hospital, China. Women in the esketamine group received a single intravenous injection of 0.2 mg/kg esketamine after sensory block level achieved. The incidence of hypotension in the esketamine group was significantly lower than the control group at T2 (10% [6 of 60]; P < 0.001), T3 (5.0% [3 of 60]; P = 0.007) and T4(5.0% [3 of 60]; P = 0.004). Despite being higher in the esketamine group, the overall rates of hypertension (11.7% [7 of 60]; P = 0.186), tachycardia (23.3% [14 of 60]; P = 0.246), and bradycardia (0.0% [0 of 60]; P = 0.079) were no significantly difference between the two groups. STAI-S scores was significantly lower in the esketamine group (mean [SD] 37.52[7.14]) than in the control group (mean [SD] 41.03[9.66], P = 0.39) in postoperative day 1. Spinal anesthesia combined with intravenous low-doses esketamine infusion can significantly reduce the incidence of hypotension in women with preoperative anxiety undergoing elective cesarean section.