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The efficacy and safety of ciprofol and propofol in patients undergoing colonoscopy: A double-blind, randomized, controlled trial - 25/04/24

Doi : 10.1016/j.jclinane.2024.111474 
Shi-Hui Gao a, b, 1, Qian-Qian Tang a, b, 1, Chang-Ming Wang b, , Zhan-Ying Guan c, Ling-Ling Wang a, b, Jing Zhang b, Zeng-Long Yan d
a The Dalian Medical University, Dalian, China 
b Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), Shenyang, China 
c Department of Anesthesiology, Jinqiu Hospital of Liaoning Province, Shenyang, China 
d Third Department of Extraskeletal Surgery, People's Hospital of China Medical University (Liao Ning Provical People's Hospital), Shen Yang, China 

Corresponding author at: Department of Anesthesiology, People's Hospital of China Medical University (People's Hospital of Liaoning Province), 33 Wenyi Road, 110016 Shenyang, China.Department of AnesthesiologyPeople's Hospital of China Medical University (People's Hospital of Liaoning Province33 Wenyi RoadShenyang110016China

Abstract

Study objective

Propofol is a commonly utilized anesthetic for painless colonoscopy, but its usage is occasionally limited due to its potential side effects, including cardiopulmonary suppression and injection pain. To address this limitation, the novel compound ciprofol has been proposed as a possible alternative for propofol. This study sought to determine whether there are any differences in the safety and efficacy of propofol and ciprofol for painless colonoscopy.

Design

Randomized clinical trial.

Setting

Single-centre, class A tertiary hospital, November 2021 to November 2022.

Patients

Adult, American Society of Anesthesiologists Physical Status I to II and body mass index of 18 to 30 kg m−2 patients scheduled to undergo colonoscopy.

Interventions

Consecutive patients were randomly allocated in a 1:1 ratio to receive sedation for colonoscopy with ciprofol (group C) or propofol (group P).

Measurements

The primary outcome was the success rate of colonoscopy. The secondary outcomes were onset time of sedation, operation time, recovery time and discharge time, patients and endoscopists satisfaction, side effects (e.g. injection pain, myoclonus, drowsiness, dizziness, procedure recall, nausea and vomiting) and incidence rate of cardiopulmonary adverse events.

Main results

No significant difference was found in the success rate of colonoscopy between the two groups (ciprofol 96.3% vs. propofol 97.6%; mean difference − 1.2%, 95% CI: −6.5% to 4.0%, P = 0.650). However, group C showed prolonged sedation (63.4 vs. 54.8 s, P < 0.001) and fully alert times (9 vs 8 min, P = 0.013), as well as reduced incidences of injection pain (0 vs. 40.2%, P < 0.001), respiratory depression (2.4% vs. 13.4%, P = 0.021) and hypotension (65.9% vs. 80.5%, P = 0.034). Patients satisfaction was also higher in Group C (10 vs 9, P < 0.001).

Conclusions

Ciprofol can be used independently for colonoscopy. When comparing the sedation efficacy of ciprofol and propofol, a 0.4 mg kg−1 dose of ciprofol proved to be equal to a 2.0 mg kg−1 dose of propofol, with fewer side effects and greater patient satisfaction during the procedure.

Le texte complet de cet article est disponible en PDF.

Highlights

Compared to the combination of ciprofol and opioids, ciprofol alone can still achieve a high success rates of colonoscopy.
Both are similar in efficacy, but ciprofol has a higher safety profile that making it more suitable for colonoscopy.
Less side effects and higher patient satisfaction of ciprofol compared with propofol.

Le texte complet de cet article est disponible en PDF.

Keywords : Ciprofol, Propofol, Colonoscopy, Sedation


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