Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-10

Study Completion Date

2024-09-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Painless Hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ciprofol group (ciprofol combined with alfentanil)

Group Type EXPERIMENTAL

Ciprofol

Intervention Type DRUG

The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911).

Propofol group (propofol combined with alfentanil)

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).

Interventions

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Ciprofol

The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911).

Intervention Type DRUG

Propofol

The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No