Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy

Not Applicable

Completed

• Conditions: Hysteroscopy; Ciprofol
• Interventions: Drug: Propofol group; Drug: Ciprofol group

• Registration Number: NCT06172140
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Eligible patients undergoing hysteroscopy were randomly assigned in a 1:1 ratio to receive intravenous anesthesia with either propofol (2 mg/kg) or remifentanil (0.4 mg/kg).Continuous monitoring of pulse oximetry (SpO2), blood pressure (BP), heart rate (HR), expired gas partial pressure of carbon dioxide, integrated respiratory index (IPI), tidal volume (TV), respiratory rate (RR), and minute ventilation (MV) was performed.During induction, the MOAA/S score was assessed every 30 seconds. If the MOAA/S score remained \>1, a supplementary dose of 1/2 of the initial dose was injected within 10 seconds.If more than 5 supplementary doses were required within 15 minutes, it was considered that the painless hysteroscopy failed and propofol was used to enhance sedation.Continuous oxygen administration at a flow rate of 5 liters per minute was provided through nasal catheters until the patient was fully alert with a MOAA/S score of 5 and vital signs were stable.Observation indicators included: (1) the success rate of hysteroscopy;(2) induction time (MOAA/S ≤ 1 after the first dose);(3) full recovery time of consciousness;(4) operation duration;(5) number of additional anesthetics;(6) incidence of hypotension, hypoxemia, sinus bradycardia, delayed recovery, and injection pain;(7) respiratory parameters and minimum SpO2, IPI values before anesthesia, after induction, and after awakening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-15
• Study Start: 2024-01-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

• Voluntary signing of informed consent form
• Stable vital signs and qualified anesthesia outpatient evaluation
• No contraindications to anesthesia

Exclusion Criteria

• Not willing to sign informed consent form
• Anaesthesia drug allergy
• Severe central nervous system diseases
• Severe hypertension and diabetes
• Mental disorders
• History of using psychotropic drugs in the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol group	Intravenous injection of propofol
Ciprofol group	Ciprofol group	Intravenous injection of ciprofol

Primary Outcome Measures

Name	Time	Method
Success rate of painless hysteroscopy	During procedure (The inspection is completed and the vaginal speculum is removed)	During the induction of sedation, the anaesthesiologist evaluated the MOAA/S score every 30 s. If the MOAA/S score remained \>1 after 2 min of initial administration of the study drug, a top-up dose of 1/2 the initial dose was injected over 10 s. During the maintenance phase, supplementary doses are given when the MOAA/S score is\>1, and repeated every 2 minutes as needed. If more than 5 additional doses are required within 15 minutes, it is considered a failure of painless hysteroscopy .

Trial Locations

Locations (1)

Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit; 🇨🇳 Guangzhou, Guangdong, China