Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
- Conditions
- Painless Hysteroscopy
- Interventions
- Registration Number
- NCT06413862
- Lead Sponsor
- Baoding First Central Hospital
- Brief Summary
Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.
- Detailed Description
In this study, we found that sedation success rate was 100% in both ciprofol group and propofol group during the painless hysteroscopy. The incidence rate of injection pain and the intensity of pain in the ciprofol group were significantly lower than the propofol group. Also, the ciprofol group had lower incidence rate and severity level of adverse events and higher patient satisfaction. In addition, SBP, DBP, and MAP values in propofol group were found to be significantly lower than those in ciprofol group at the time of cervical dilation and of consciousness recovery.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 188
- age ≥ 18 years old;
- undergoing hysteroscopy examination and requiring intravenous anesthesia;
- American Society of Anesthesiologists (ASA) physical status I to II;
- without communication difficulties, and able to cooperate with intervention implementation;
- participating in this trial voluntarily, and signing an informed consent form;
- with contraindications for hysteroscopy examination (such as cervical stenosis, difficulty in cervical dilation, reproductive tract infections such as vaginitis and cervicitis) or allergies to the intended anesthetic drugs;
- with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases;
- with a history of uterine surgery within the past three months;
- body temperature above 37.5 ℃ before the anesthesia;
- long-term use of sedative or analgesic drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ciprofol group (ciprofol combined with alfentanil) Ciprofol - Propofol group (propofol combined with alfentanil) Propofol -
- Primary Outcome Measures
Name Time Method Injection pain 24 hours within hysteroscopy The injection pain was defined as the pain reported verbally by patients during the first injection of the investigational drugs (ciprofol or propofol). The Numerical Rating Scale (NRS) was used to evaluate the pain level. The anesthesiologist asks the patient during the first injection of the investigational drug (ciprofol or propofol), "Do you feel arm pain from the injection? Patients who answered "yes" was asked to describe the level of the pain (a score of 0 to 10 indicated "painless" to "unbearable pain"). The pain level was divided into painless (0 points), mild pain (1-3 points), and moderate to severe pain (4-10 points).
- Secondary Outcome Measures
Name Time Method times of supplementing ciprofol or propofol 24 hours within hysteroscopy times of supplementing ciprofol or propofol
recovery time 24 hours within hysteroscopy the time from the last administration of investigational drugs to awaken
adverse events 24 hours within hysteroscopy nausea, vomiting, hypoxemia (blood oxygen saturation \< 90% and lasting \> 30 seconds), bradycardia (heart rate \< 55 beats/minute), hypotension (systolic blood pressure reduced by 20% compared to baseline), body movement (patient's unconscious limb movements) during the examination
Anesthesia success rate 24 hours within hysteroscopy the absence of any alternative sedatives/anesthetic drugs after the initial administration of the investigational drugs
Sedation success rate 24 hours within hysteroscopy No more than 5 supplementary doses within 15 minutes
use of rescue drugs 24 hours within hysteroscopy ephedrine, atropine
time for successful anesthesia induction 24 hours within hysteroscopy the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1
comparison of vital signs before and after administration 24 hours within hysteroscopy The systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, blood oxygen saturation in %, and heart rate in bpm were recorded before anesthesia induction (T0), after anesthesia induction (T1), at cervical dilation (T2), and at consciousness recovery (T3)
severity level of adverse events 24 hours within hysteroscopy graded based the National Cancer Institute Common Terminology Criteria for the Classification of Adverse Events (CTCAE) version 5.0, and divided into grade 1 (mild), grade 2 (moderate), grade 3 (severe or medically significant but not immediately life threatening), grade 4 (events with life-threatening consequences needing urgent intervention), grade 5 (death related to the adverse events)
patient satisfaction 24 hours within hysteroscopy using a 10-point scale, with 1 point indicating extreme dissatisfaction and 10 points indicating very satisfied