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

Hysteroscopy Clinical Trial

Official title:

Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy: A Prospective, Randomized, Non-inferiority Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172140
• Other study ID #: SYSKY-2023-1091-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Ganglan Fu, PhD
• Phone: 13570275074
• Email: fugangl[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: September 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of painless hysteroscopy	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 .	During procedure (The inspection is completed and the vaginal speculum is removed)