Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

Baoding First Central Hospital

Status: Not yet enrolling

Conditions: Painless Hysteroscopy

Treatments: Drug: Propofol; Drug: Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06413862

Ciprofol in hysteroscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 2 patient groups

Ciprofol group (ciprofol combined with alfentanil)

Experimental group

Treatment:

Drug: Ciprofol

Propofol group (propofol combined with alfentanil)

Active Comparator group

Treatment:

Drug: Propofol