Clinical trial NCT06413862: Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
Official title: Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Painless Hysteroscopy
Lead sponsor: Baoding First Central Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 188
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years old;
2. undergoing hysteroscopy examination and requiring intravenous anesthesia;
3. American Society of Anesthesiologists (ASA) physical status I to II;
4. without communication difficulties, and able to cooperate with intervention implementation;
5. participating in this trial voluntarily, and signing an informed consent form;

Exclusion Criteria:

1. 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;
2. with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases;
3. with a history of uterine surgery within the past three months;
4. body temperature above 37.5 ℃ before the anesthesia;
5. long-term use of sedative or analgesic drugs.

Primary outcomes:
measure: Injection pain
timeFrame: 24 hours within hysteroscopy
Secondary outcomes:
measure: Sedation success rate
timeFrame: 24 hours within hysteroscopy
measure: Anesthesia success rate
timeFrame: 24 hours within hysteroscopy
measure: time for successful anesthesia induction
timeFrame: 24 hours within hysteroscopy
measure: recovery time
timeFrame: 24 hours within hysteroscopy
measure: use of rescue drugs
timeFrame: 24 hours within hysteroscopy
measure: times of supplementing ciprofol or propofol
timeFrame: 24 hours within hysteroscopy
measure: adverse events
timeFrame: 24 hours within hysteroscopy
measure: severity level of adverse events
timeFrame: 24 hours within hysteroscopy
measure: patient satisfaction
timeFrame: 24 hours within hysteroscopy
measure: comparison of vital signs before and after administration
timeFrame: 24 hours within hysteroscopy
Other outcomes:
Locations:
Study officials:
affiliation: the First Central Hospital of Baoding
name: Lei Zhu
role: PRINCIPAL_INVESTIGATOR
References: