The EC90 of remifentanil for inhibiting endotracheal intubation responses under anesthesia induction with ciprofol: study protocol for a dose-finding trial with the biased-coin design.
Humans
Remifentanil
/ administration & dosage
Intubation, Intratracheal
/ methods
Prospective Studies
Heart Rate
/ drug effects
Male
Anesthetics, Intravenous
/ administration & dosage
Female
Adult
Dose-Response Relationship, Drug
Middle Aged
Arterial Pressure
/ drug effects
Hemodynamics
/ drug effects
Rocuronium
/ administration & dosage
Analgesics, Opioid
/ administration & dosage
90% effective dose
Biased-coin design
Cardiovascular responses to tracheal intubation
Ciprofol
Dose-finding trial
Remifentanil
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Aug 2024
23 Aug 2024
Historique:
received:
15
01
2024
accepted:
12
08
2024
medline:
24
8
2024
pubmed:
24
8
2024
entrez:
23
8
2024
Statut:
epublish
Résumé
Tracheal intubation may cause significant hemodynamic responses. Many drugs have been shown to be effective in modifying these cardiovascular responses, including remifentanil, fentanyl, sufentanil, and alfentanil. However, the 90% effect-site concentration (EC90) of remifentanil required to control cardiovascular responses to tracheal intubation when combined with ciprofol remains unclear. The purpose of this study was to determine the EC90 of remifentanil inhibiting cardiovascular responses to tracheal intubation during anesthesia induction with ciprofol using biased-coin design up-and-down sequential method (BC-UDM). This is a prospective sequential allocation dose-finding study. American Society of Anesthesiologists physical status (ASA) I-II elective surgical patients receiving target-controlled infusion (TCI) of remifentanil effect-site concentration (Ce), followed by ciprofol and rocuronium for anesthesia, were enrolled. The cardiovascular response to tracheal intubation was defined as positive when mean arterial pressure (MAP) or heart rate (HR) is 15% higher than the baseline value. Using the BC-UDM, the Ce of remifentanil was determined based on the cardiovascular response to tracheal intubation of the previous patient. The EC90 and 90% confidence intervals (90% CIs) were estimated by R-Foundation centered isotonic regression and the pooled adjacent violators algorithm with bootstrapping. The results of this study sought to demonstrate EC90 of remifentanil blunting sympathetic responses to tracheal intubation during anesthesia index (Ai)-guided ciprofol anesthesia using BCD-UDM. It may help to minimize the cardiovascular responses to tracheal intubation. Chinese Clinical Trial Registry ChiCTR2300078275. Registered on December 3, 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Tracheal intubation may cause significant hemodynamic responses. Many drugs have been shown to be effective in modifying these cardiovascular responses, including remifentanil, fentanyl, sufentanil, and alfentanil. However, the 90% effect-site concentration (EC90) of remifentanil required to control cardiovascular responses to tracheal intubation when combined with ciprofol remains unclear. The purpose of this study was to determine the EC90 of remifentanil inhibiting cardiovascular responses to tracheal intubation during anesthesia induction with ciprofol using biased-coin design up-and-down sequential method (BC-UDM).
METHODS
METHODS
This is a prospective sequential allocation dose-finding study. American Society of Anesthesiologists physical status (ASA) I-II elective surgical patients receiving target-controlled infusion (TCI) of remifentanil effect-site concentration (Ce), followed by ciprofol and rocuronium for anesthesia, were enrolled. The cardiovascular response to tracheal intubation was defined as positive when mean arterial pressure (MAP) or heart rate (HR) is 15% higher than the baseline value. Using the BC-UDM, the Ce of remifentanil was determined based on the cardiovascular response to tracheal intubation of the previous patient. The EC90 and 90% confidence intervals (90% CIs) were estimated by R-Foundation centered isotonic regression and the pooled adjacent violators algorithm with bootstrapping.
DISCUSSION
CONCLUSIONS
The results of this study sought to demonstrate EC90 of remifentanil blunting sympathetic responses to tracheal intubation during anesthesia index (Ai)-guided ciprofol anesthesia using BCD-UDM. It may help to minimize the cardiovascular responses to tracheal intubation.
TRIAL REGISTRATION
BACKGROUND
Chinese Clinical Trial Registry ChiCTR2300078275. Registered on December 3, 2023.
Identifiants
pubmed: 39180100
doi: 10.1186/s13063-024-08397-y
pii: 10.1186/s13063-024-08397-y
doi:
Substances chimiques
Remifentanil
P10582JYYK
Anesthetics, Intravenous
0
Rocuronium
WRE554RFEZ
Analgesics, Opioid
0
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
558Informations de copyright
© 2024. The Author(s).
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