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

NCT ID: NCT06172140

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-04-30

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.

Conditions

Ciprofol; Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ciprofol group

Intravenous injection of ciprofol

Group Type: EXPERIMENTAL

Ciprofol group

Intervention Type: DRUG

All patients received 5 μ g of sufentanil 1 minute before intravenous infusion of ciprofol, followed by intravenous injection of ciprofol (0.4mg/kg). When the MOAA/S score is ≤ 1, vaginal disinfection begins. During the induction of sedation, the MOAA/S score is evaluated every 30 seconds. If the MOAA/S score remains above 1, a supplementary dose of 1/2 of the initial dose is injected within 10 seconds. During the maintenance phase, supplementary doses are given when there are signs of physical activity, eye opening, or speech. If more than 5 additional doses are required within 15 minutes, painless hysteroscopy is considered a failure, and propofol is immediately used to enhance sedation.

Propofol group

Intravenous injection of propofol

Group Type: EXPERIMENTAL

Propofol group

Intervention Type: DRUG

All patients received 5 μ g of sufentanil 1 minute before intravenous infusion of propofol, followed by intravenous injection of propofol (2 mg/kg) for 30 seconds. When the MOAA/S score is ≤ 1, vaginal disinfection begins. During the induction of sedation, the MOAA/S score is evaluated every 30 seconds. If the MOAA/S score remains above 1, a supplementary dose of 1/2 of the initial dose is injected within 10 seconds. During the maintenance phase, supplementary doses are given when there are signs of physical activity, eye opening, or speech. If more than 5 additional doses are required within 15 minutes, painless hysteroscopy is considered a failure, and propofol is immediately used to enhance sedation.

Interventions

Ciprofol group

All patients received 5 μ g of sufentanil 1 minute before intravenous infusion of ciprofol, followed by intravenous injection of ciprofol (0.4mg/kg). When the MOAA/S score is ≤ 1, vaginal disinfection begins. During the induction of sedation, the MOAA/S score is evaluated every 30 seconds. If the MOAA/S score remains above 1, a supplementary dose of 1/2 of the initial dose is injected within 10 seconds. During the maintenance phase, supplementary doses are given when there are signs of physical activity, eye opening, or speech. If more than 5 additional doses are required within 15 minutes, painless hysteroscopy is considered a failure, and propofol is immediately used to enhance sedation.

Intervention Type: DRUG

Propofol group

All patients received 5 μ g of sufentanil 1 minute before intravenous infusion of propofol, followed by intravenous injection of propofol (2 mg/kg) for 30 seconds. When the MOAA/S score is ≤ 1, vaginal disinfection begins. During the induction of sedation, the MOAA/S score is evaluated every 30 seconds. If the MOAA/S score remains above 1, a supplementary dose of 1/2 of the initial dose is injected within 10 seconds. During the maintenance phase, supplementary doses are given when there are signs of physical activity, eye opening, or speech. If more than 5 additional doses are required within 15 minutes, painless hysteroscopy is considered a failure, and propofol is immediately used to enhance sedation.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit

Guangzhou, Guangdong, China

Countries

China

References

Cheng S, Wu H, Liu Z, Liu D, Cao M, Fu G. Efficacy and safety of ciprofol for sedation/anesthesia in patients undergoing hysteroscopy: a prospective, randomized, non-inferiority trial. Ann Med. 2025 Dec;57(1):2517820. doi: 10.1080/07853890.2025.2517820. Epub 2025 Jun 18.

Reference Type: DERIVED

PMID: 40530830 (View on PubMed)

Other Identifiers

SYSKY-2023-1091-02

Identifier Type: -

Identifier Source: org_study_id