Effects of a Ciprofol-Etomidate Mixture on Intraoperative Hypoxemia and Hypotension in Older Patients Undergoing Gastrointestinal Endoscopy Under Sedation: A Randomized Controlled Trial

Abstract Objective To evaluate the efficacy and safety of a 1:1 ciprofol-etomidate mixture for sedation during combined gastrointestinal endoscopy in older patients and to provide evidence for optimizing clinical sedation strategies. Methods This single-center, prospective, double-blind, randomized controlled trial enrolled 203 patients aged 60–80 years who were scheduled to undergo combined gastrointestinal endoscopy under sedation. Patients were randomly assigned to receive either ciprofol alone (Group C, n = 101) or a ciprofol-etomidate mixture (Group CE, n = 102). Patients in Group C received intravenous ciprofol at a dose of 0.3 mg/kg, whereas those in Group CE received a slow intravenous injection of a ciprofol-etomidate mixture comprising ciprofol 0.15 mg/kg and etomidate 0.12 mg/kg over 1 min. The primary outcome was the composite incidence of intraoperative hypotension and hypoxemia. Secondary outcomes included adverse events, sedation onset time, first-dose sedation success rate, recovery time, and satisfaction scores reported by patients, anesthesiologists, and endoscopists. Results The incidence of the composite outcome of intraoperative hypotension and hypoxemia was significantly lower in Group CE than in Group C (P < 0.05). Group CE also had significantly lower incidences of hypotension (21.2% vs. 42.3%) and vasopressor use (15.4% vs. 34.6%) (both P = 0.001). Sedation onset was significantly faster in Group CE than in Group C (61.0 ± 6.1 s vs. 71.1 ± 14.4 s), the first-dose sedation success rate was higher (97.1% vs. 89.4%), and recovery time was shorter (18.3 ± 3.8 min vs. 19.6 ± 4.2 min) (all P < 0.05). The incidences of myoclonus and injection pain did not differ significantly between the groups ( P > 0.05). Anesthesiologist satisfaction was significantly higher in Group CE than in Group C (P < 0.001), whereas patient and endoscopist satisfaction scores were comparable between the groups. Conclusion A 1:1 ciprofol-etomidate mixture improves hemodynamic stability, accelerates sedation onset, and increases the first-dose sedation success rate in older patients undergoing gastrointestinal endoscopy under sedation, without increasing adverse events. This regimen may enhance the efficiency of anesthesia management and represents a potentially useful clinical sedation strategy. Trial registration The trial was registered with the Chinese Clinical Trial Registry (ChiCTR2500103032, https//www.chictr.org.cn/)on 23/05/2025.

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Research Square
Published
2026-11-07
DOI
https://doi.org/10.21203/rs.3.rs-10931663/v1
Primary Topic
Anesthesia and Sedative Agents
Type
preprint
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preprint

Effects of a Ciprofol-Etomidate Mixture on Intraoperative Hypoxemia and Hypotension in Older Patients Undergoing Gastrointestinal Endoscopy Under Sedation: A Randomized Controlled Trial

Pingle Li, Na Xing, Xulin Wang, Jianwen Zhang
7 links
Research Square
Anesthesia and Sedative Agents
preprint

Effects of a Ciprofol-Etomidate Mixture on Intraoperative Hypoxemia and Hypotension in Older Patients Undergoing Gastrointestinal Endoscopy Under Sedation: A Randomized Controlled Trial

Pingle Li, Na Xing, Xulin Wang, Jianwen Zhang
preprint en

Abstract

Abstract Objective To evaluate the efficacy and safety of a 1:1 ciprofol-etomidate mixture for sedation during combined gastrointestinal endoscopy in older patients and to provide evidence for optimizing clinical sedation strategies. Methods This single-center, prospective, double-blind, randomized controlled trial enrolled 203 patients aged 60–80 years who were scheduled to undergo combined gastrointestinal endoscopy under sedation. Patients were randomly assigned to receive either ciprofol alone (Group C, n = 101) or a ciprofol-etomidate mixture (Group CE, n = 102). Patients in Group C received intravenous ciprofol at a dose of 0.3 mg/kg, whereas those in Group CE received a slow intravenous injection of a ciprofol-etomidate mixture comprising ciprofol 0.15 mg/kg and etomidate 0.12 mg/kg over 1 min. The primary outcome was the composite incidence of intraoperative hypotension and hypoxemia. Secondary outcomes included adverse events, sedation onset time, first-dose sedation success rate, recovery time, and satisfaction scores reported by patients, anesthesiologists, and endoscopists. Results The incidence of the composite outcome of intraoperative hypotension and hypoxemia was significantly lower in Group CE than in Group C (P < 0.05). Group CE also had significantly lower incidences of hypotension (21.2% vs. 42.3%) and vasopressor use (15.4% vs. 34.6%) (both P = 0.001). Sedation onset was significantly faster in Group CE than in Group C (61.0 ± 6.1 s vs. 71.1 ± 14.4 s), the first-dose sedation success rate was higher (97.1% vs. 89.4%), and recovery time was shorter (18.3 ± 3.8 min vs. 19.6 ± 4.2 min) (all P < 0.05). The incidences of myoclonus and injection pain did not differ significantly between the groups ( P > 0.05). Anesthesiologist satisfaction was significantly higher in Group CE than in Group C (P < 0.001), whereas patient and endoscopist satisfaction scores were comparable between the groups. Conclusion A 1:1 ciprofol-etomidate mixture improves hemodynamic stability, accelerates sedation onset, and increases the first-dose sedation success rate in older patients undergoing gastrointestinal endoscopy under sedation, without increasing adverse events. This regimen may enhance the efficiency of anesthesia management and represents a potentially useful clinical sedation strategy. Trial registration The trial was registered with the Chinese Clinical Trial Registry (ChiCTR2500103032, https//www.chictr.org.cn/)on 23/05/2025.

Research Square
First Affiliated Hospital of Zhengzhou University (CN)
Good health and well-being
Anesthesia and Sedative Agents
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