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

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.

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Key information

Conditions

Ciprofol Hysteroscopy

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciprofol group

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

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.

Primary outcomes

Success rate of painless hysteroscopy

Time frame: 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 .

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Dec 15, 2023
Registry last updated: Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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