Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

Официальное название

Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ciprofol
  The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911).
• Препарат Propofol
  The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).

Первичные конечные точки

• Injection pain [Срок оценки: 24 hours within hysteroscopy]

Вторичные конечные точки (10)

• Sedation success rate [Срок оценки: 24 hours within hysteroscopy]
• Anesthesia success rate [Срок оценки: 24 hours within hysteroscopy]
• time for successful anesthesia induction [Срок оценки: 24 hours within hysteroscopy]
• recovery time [Срок оценки: 24 hours within hysteroscopy]
• use of rescue drugs [Срок оценки: 24 hours within hysteroscopy]
• times of supplementing ciprofol or propofol [Срок оценки: 24 hours within hysteroscopy]
• adverse events [Срок оценки: 24 hours within hysteroscopy]
• severity level of adverse events [Срок оценки: 24 hours within hysteroscopy]
• patient satisfaction [Срок оценки: 24 hours within hysteroscopy]
• comparison of vital signs before and after administration [Срок оценки: 24 hours within hysteroscopy]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06413862 · Ciprofol in hysteroscopy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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