Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study

Abstract Background Maternal hypotension after spinal anaesthesia occurs at a high rate during caesarean delivery and can lead to adverse maternal or foetal outcomes. The aim of this study was to determine the optimal dose of spinal ropivacaine for caesarean section with or without intravenous singl...

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Autores principales: Xiaoyu Zhang, Jianwei Wang, Xiao-Hu An, Yu-Chieh Chao, Yong Bian, Zifeng Xu, Tao Xu
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Publicado: BMC 2021
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spelling oai:doaj.org-article:04a4235f875e4497a7d667073d99d7592021-11-08T11:04:11ZOptimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study10.1186/s12884-021-04229-y1471-2393https://doaj.org/article/04a4235f875e4497a7d667073d99d7592021-11-01T00:00:00Zhttps://doi.org/10.1186/s12884-021-04229-yhttps://doaj.org/toc/1471-2393Abstract Background Maternal hypotension after spinal anaesthesia occurs at a high rate during caesarean delivery and can lead to adverse maternal or foetal outcomes. The aim of this study was to determine the optimal dose of spinal ropivacaine for caesarean section with or without intravenous single bolus of S-ketamine and to observe the rates of hypotension associated with both methods. Methods Eighty women undergoing elective caesarean delivery were randomly allocated into either a ropivacaine only or ropivacaine with intravenous S-ketamine group. If the upper sensory level of the patient reached T6 and the visual analogue scale (VAS) scores remained below 3 points before delivery, the next patient had a 1/9th chance of receiving a lower dose or an 8/9th chance of receiving the same dose as the previous patient. If the patient had VAS scores of more than 2 points or needed an extra epidural rescue bolus before delivery, a higher dose was used for the next patient. The primary outcome was the successful use of spinal ropivacaine to maintain patient VAS score of < 3 points before delivery and the incidence of post-spinal hypotension in both groups. Secondary outcomes included the rates of hypotension-related symptoms and interventions, upper sensory level of anaesthesia, level of sedation, neonatal outcomes, Edinburgh Postnatal Depression Scale scores at admission and discharge, and post-operative analgesic effect. The 90% effective dose (ED90) and 95% confidence interval (95% CI) were estimated by isotonic regression. Results The estimated ED90 of ropivacaine was 11.8 mg (95% CI: 11.7–12.7) with and 14.7 mg (95% CI: 14.6–16.0) without intravenous S-ketamine, using biased coin up-down sequential dose-finding method. The rates of hypotension and associated symptoms were significantly lower in S-ketamine group than in the ropivacaine only group. Conclusions A spinal dose of ropivacaine 12 mg with a single intravenous 0.15 mg/kg bolus dose of S-ketamine may significantly reduce the risk of hypotension and induce sedation before delivery. This method may be used with appropriate caution for women undergoing elective caesarean delivery and at a high risk of hypotension or experiencing extreme nervousness. Trial registration http://www.chictr.org.cn ( ChiCTR2000040375 ; 28/11/2020).Xiaoyu ZhangJianwei WangXiao-Hu AnYu-Chieh ChaoYong BianZifeng XuTao XuBMCarticleED90RopivacainePost-spinal hypotensionS-ketamineCaesarean deliveryPost-operative analgesiaGynecology and obstetricsRG1-991ENBMC Pregnancy and Childbirth, Vol 21, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic ED90
Ropivacaine
Post-spinal hypotension
S-ketamine
Caesarean delivery
Post-operative analgesia
Gynecology and obstetrics
RG1-991
spellingShingle ED90
Ropivacaine
Post-spinal hypotension
S-ketamine
Caesarean delivery
Post-operative analgesia
Gynecology and obstetrics
RG1-991
Xiaoyu Zhang
Jianwei Wang
Xiao-Hu An
Yu-Chieh Chao
Yong Bian
Zifeng Xu
Tao Xu
Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
description Abstract Background Maternal hypotension after spinal anaesthesia occurs at a high rate during caesarean delivery and can lead to adverse maternal or foetal outcomes. The aim of this study was to determine the optimal dose of spinal ropivacaine for caesarean section with or without intravenous single bolus of S-ketamine and to observe the rates of hypotension associated with both methods. Methods Eighty women undergoing elective caesarean delivery were randomly allocated into either a ropivacaine only or ropivacaine with intravenous S-ketamine group. If the upper sensory level of the patient reached T6 and the visual analogue scale (VAS) scores remained below 3 points before delivery, the next patient had a 1/9th chance of receiving a lower dose or an 8/9th chance of receiving the same dose as the previous patient. If the patient had VAS scores of more than 2 points or needed an extra epidural rescue bolus before delivery, a higher dose was used for the next patient. The primary outcome was the successful use of spinal ropivacaine to maintain patient VAS score of < 3 points before delivery and the incidence of post-spinal hypotension in both groups. Secondary outcomes included the rates of hypotension-related symptoms and interventions, upper sensory level of anaesthesia, level of sedation, neonatal outcomes, Edinburgh Postnatal Depression Scale scores at admission and discharge, and post-operative analgesic effect. The 90% effective dose (ED90) and 95% confidence interval (95% CI) were estimated by isotonic regression. Results The estimated ED90 of ropivacaine was 11.8 mg (95% CI: 11.7–12.7) with and 14.7 mg (95% CI: 14.6–16.0) without intravenous S-ketamine, using biased coin up-down sequential dose-finding method. The rates of hypotension and associated symptoms were significantly lower in S-ketamine group than in the ropivacaine only group. Conclusions A spinal dose of ropivacaine 12 mg with a single intravenous 0.15 mg/kg bolus dose of S-ketamine may significantly reduce the risk of hypotension and induce sedation before delivery. This method may be used with appropriate caution for women undergoing elective caesarean delivery and at a high risk of hypotension or experiencing extreme nervousness. Trial registration http://www.chictr.org.cn ( ChiCTR2000040375 ; 28/11/2020).
format article
author Xiaoyu Zhang
Jianwei Wang
Xiao-Hu An
Yu-Chieh Chao
Yong Bian
Zifeng Xu
Tao Xu
author_facet Xiaoyu Zhang
Jianwei Wang
Xiao-Hu An
Yu-Chieh Chao
Yong Bian
Zifeng Xu
Tao Xu
author_sort Xiaoyu Zhang
title Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
title_short Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
title_full Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
title_fullStr Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
title_full_unstemmed Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
title_sort optimum dose of spinal ropivacaine with or without single intravenous bolus of s-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study
publisher BMC
publishDate 2021
url https://doaj.org/article/04a4235f875e4497a7d667073d99d759
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