Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ciprofol, Propofol.
- Who it may be relevant to
- Registry conditions: Painless Hysteroscopy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy
Overview
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.
Interventions
- Drug Ciprofol
The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911). - Drug Propofol
The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).
Primary outcome measures
- Injection pain [Time frame: 24 hours within hysteroscopy]
Secondary outcome measures (10)
- Sedation success rate [Time frame: 24 hours within hysteroscopy]
- Anesthesia success rate [Time frame: 24 hours within hysteroscopy]
- time for successful anesthesia induction [Time frame: 24 hours within hysteroscopy]
- recovery time [Time frame: 24 hours within hysteroscopy]
- use of rescue drugs [Time frame: 24 hours within hysteroscopy]
- times of supplementing ciprofol or propofol [Time frame: 24 hours within hysteroscopy]
- adverse events [Time frame: 24 hours within hysteroscopy]
- severity level of adverse events [Time frame: 24 hours within hysteroscopy]
- patient satisfaction [Time frame: 24 hours within hysteroscopy]
- comparison of vital signs before and after administration [Time frame: 24 hours within hysteroscopy]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Li A, Li N, Zhu L, Xu Z, Wang Y, Li J, Zhang G. The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy: a randomized, double-blind, controlled trial. BMC Anesthesiol. 2024 Nov 12;24(1):411. doi: 10.1186/s12871-024-02787-0. PMID 39533194
Identifiers
NCT: NCT06413862 · Ciprofol in hysteroscopy