Efficacy and Safety of Ciprofol for the Sedation in Patients Undergoing Hysteroscopy
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University