Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Zhang, Xiaoyu, Wang, Jianwei, An, Xiao-Hu, Chao, Yu-Chieh, Bian, Yong, Xu, Zifeng, Xu, Tao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567718/
https://www.ncbi.nlm.nih.gov/pubmed/34736438
http://dx.doi.org/10.1186/s12884-021-04229-y
_version_ 1784594293085700096
author Zhang, Xiaoyu
Wang, Jianwei
An, Xiao-Hu
Chao, Yu-Chieh
Bian, Yong
Xu, Zifeng
Xu, Tao
author_facet Zhang, Xiaoyu
Wang, Jianwei
An, Xiao-Hu
Chao, Yu-Chieh
Bian, Yong
Xu, Zifeng
Xu, Tao
author_sort Zhang, Xiaoyu
collection PubMed
description 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). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12884-021-04229-y.
format Online
Article
Text
id pubmed-8567718
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-85677182021-11-04 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 Zhang, Xiaoyu Wang, Jianwei An, Xiao-Hu Chao, Yu-Chieh Bian, Yong Xu, Zifeng Xu, Tao BMC Pregnancy Childbirth Research 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). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12884-021-04229-y. BioMed Central 2021-11-04 /pmc/articles/PMC8567718/ /pubmed/34736438 http://dx.doi.org/10.1186/s12884-021-04229-y Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Zhang, Xiaoyu
Wang, Jianwei
An, Xiao-Hu
Chao, Yu-Chieh
Bian, Yong
Xu, Zifeng
Xu, Tao
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 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_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_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
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567718/
https://www.ncbi.nlm.nih.gov/pubmed/34736438
http://dx.doi.org/10.1186/s12884-021-04229-y
work_keys_str_mv AT zhangxiaoyu optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy
AT wangjianwei optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy
AT anxiaohu optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy
AT chaoyuchieh optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy
AT bianyong optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy
AT xuzifeng optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy
AT xutao optimumdoseofspinalropivacainewithorwithoutsingleintravenousbolusofsketamineduringelectivecesareandeliveryarandomizeddoubleblindsequentialdosefindingstudy