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NCT06172140

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

Completed NA Last updated 21 August 2024
What this trial tests

NA trial testing Ciprofol group in Ciprofol in 124 participants. Completed in 30 April 2024.

Timeline
1 January 2024
Primary endpoint
30 April 2024
30 April 2024

Quick facts

Lead sponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment124
Start date1 January 2024
Primary completion30 April 2024
Estimated completion30 April 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

Adults 18 to 65, female only, with Ciprofol or Hysteroscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and safety of ciprofol for sedation/anesthesia in patients undergoing hysteroscopy: a prospective, randomized, non-inferiority trial.
    Cheng S, Wu H, Liu Z, Liu D, et al · · 2025 · cited 2× · PMID 40530830 · DOI 10.1080/07853890.2025.2517820

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Other trials of Ciprofol group

Trials testing the same drug.

Other recruiting trials for Ciprofol

Currently open trials in the same condition.

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

Trials by the same sponsor.

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Data sources for this page

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