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"Anaesthesia"
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Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: a pragmatic randomised triaL (VITAL)
2024
Background
Improving outcomes after surgery is a major public health research priority for patients, clinicians and the NHS. The greatest burden of perioperative complications, mortality and healthcare costs lies amongst the population of patients aged over 50 years who undergo major non-cardiac surgery. The Volatile vs Total Intravenous Anaesthesia for major non-cardiac surgery (VITAL) trial specifically examines the effect of anaesthetic technique on key patient outcomes: quality of recovery after surgery (quality of recovery after anaesthesia, patient satisfaction and major post-operative complications), survival and patient safety.
Methods
A multi-centre pragmatic efficient randomised trial with health economic evaluation comparing total intravenous anaesthesia with volatile-based anaesthesia in adults (aged 50 and over) undergoing elective major non-cardiac surgery under general anaesthesia.
Discussion
Given the very large number of patients exposed to general anaesthesia every year, even small differences in outcome between the two techniques could result in substantial excess harm. Results from the VITAL trial will ensure patients can benefit from the very safest anaesthesia care, promoting an early return home, reducing healthcare costs and maximising the health benefits of surgical treatments.
Trial registration
ISRCTN62903453. September 09, 2021.
Journal Article
Neurodevelopmental outcome at 2 years of age after general anaesthesia and awake-regional anaesthesia in infancy (GAS): an international multicentre, randomised controlled trial
by
Hardy, Pollyanna
,
Wilton, Niall
,
Hunt, Rodney W
in
Age Factors
,
Anesthesia
,
Anesthesia, General - adverse effects
2016
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).
Journal Article
Ultrasound-guided caudal anaesthesia combined with epidural anaesthesia for caesarean section: a randomized controlled clinical trial
by
Wang, Fangjun
,
Yang, Zheng
,
Xie, Dan
in
Anesthesia, Caudal
,
Anesthesia, Epidural - methods
,
Anesthesia, Obstetrical - methods
2024
Background
Although epidural anaesthesia and spinal anaesthesia are currently the general choices for patients undergoing caesarean section, these two neuraxial anaesthesia methods still have drawbacks. Caudal anaesthesia has been considered to be more appropriate for gynaecological surgery. The purpose of this study was to compare epidural anaesthesia combined with caudal anaesthesia, spinal anaesthesia and single-space epidural anaesthesia for caesarean section with respect to postoperative comfort and intraoperative anaesthesia quality.
Methods
In this clinical trial, 150 patients undergoing elective caesarean section were recruited and randomized into three groups according to a ratio of 1:1:1to receive epidural anaesthesia only, spinal anaesthesia only or epidural anaesthesia combined with caudal anaesthesia. The primary outcome was postoperative comfort in the three groups. Secondary outcomes included intraoperative anaesthesia quality and the incidences of nausea, vomiting, postdural puncture headache, maternal bradycardia, or hypotension.
Results
More patients were satisfied with the intraoperative anaesthesia quality in the EAC group than in the EA group (
P
= 0.001). The obstetrician was more significantly satisfied with the intraoperative anaesthesia quality in the SA and EAC groups than in the EA group (
P
= 0.004 and 0.020, respectively). The parturients felt more comfortable after surgery in the EA and EAC groups (
P
= 0.007). The incidence of maternal hypotension during caesarean section was higher in the SA group than in the EA and EAC groups (
P
= 0.001 and 0.019, respectively).
Conclusions
Epidural anaesthesia combined with caudal anaesthesia may be a better choice for elective caesarean section. Compared with epidural anaesthesia and spinal anaesthesia, it has a higher quality of postoperative comfort and intraoperative anaesthesia.
Journal Article
Effectiveness of Remimazolam on Preventing Adverse Reactions Caused by Carboprost Tromethamine During Cesarean Section
2025
•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.
Journal Article
Effect of crystalloid solution co-loading infusion rate on the dose requirements of prophylactic phenylephrine for preventing hypotension following combined spinal-epidural anesthesia for cesarean delivery
by
Qian, Jing
,
Zhang, Xiao-Min
,
Xiao, Fei
in
Adult
,
Anesthesia
,
Anesthesia, Epidural - adverse effects
2024
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).
Journal Article
A Dose–Response Study of Four Fixed Weight-Based Phenylephrine Dosages in Obese Cesarean Delivery Patients to Prevent Spinal Anesthesia-Induced Hypotension
by
Wang, Yang
,
Xing, Li
,
Shi, Hong-Shu
in
Adult
,
Anesthesia, Epidural - adverse effects
,
Anesthesia, Epidural - methods
2024
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.
Journal Article
Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults
2021
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.
Journal Article
Correction: Transient changes in white matter microstructure during general anesthesia
by
PLOS ONE Staff
in
Anesthesia
2021
[This corrects the article DOI: 10.1371/journal.pone.0247678.].
Journal Article
Norepinephrine or phenylephrine for the prevention of post-spinal hypotension after caesarean section: A double-blinded, randomized, controlled study of fetal heart rate and fetal cardiac output
by
Xu, Li
,
Chen, XinZhong
,
Liu, Jinping
in
Adult
,
Anesthesia
,
Anesthesia, Epidural - adverse effects
2024
Spinal anesthesia often causes hypotension, with consequent risk to the fetus. The use of vasopressor agents has been highly recommended for the prevention of spinal anesthesia-induced hypotension during caesarean delivery. Many studies have shown that norepinephrine can provide more stable maternal hemodynamics than phenylephrine. We therefore tested the hypothesis that norepinephrine preserves fetal circulation better than phenylephrine when used to treat maternal hypotension consequent to spinal anesthesia.
Prospective, randomized, double-blinded study.
Operating room.
We recruited 223 parturients with uncomplicated singleton pregnancies who were scheduled for elective caesarean section under combined spinal-epidural anesthesia.
The patients received prophylactic intravenous infusion of either 0.08 μg/kg/min norepinephrine or 0.5 μg/kg/min phenylephrine for prevention of spinal anesthesia-induced hypotension.
Changes in fetal heart rate and fetal cardiac output before and after spinal anesthesia were measured using noninvasive Doppler ultrasound.
90 subjects who received norepinephrine infusion and 93 subjects who received phenylephrine infusion were ultimately analyzed in the present study. The effects of norepinephrine and phenylephrine on the change of fetal heart rate and fetal cardiac output at 3 and 6 min after spinal block were similar. Although there was a statistically significant decrease in fetal cardiac output at 6 min after subarachnoid block initiation in both the norepinephrine group (mean difference 0.02 L/min; 95% CI, 0–0.04 L/min; P = 0.03) and the phenylephrine group (mean difference 0.02 L/min; 95% CI, 0–0.04 L/min; P = 0.02), it remained within the normal range.
Prophylactic infusion of comparable doses of phenylephrine or norepinephrine has similar effects on fetal heart rate and cardiac output changes after spinal anesthesia. Neither phenylephrine nor norepinephrine has meaningful detrimental effects on fetal circulation or neonatal outcomes.
•Prophylactic infusion of comparable doses of phenylephrine or norepinephrine has similar effects on fetal heart rate and cardiac output changes after spinal anesthesia.•Neither phenylephrine nor norepinephrine has meaningful detrimental effects on fetal circulation.
Journal Article