Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

NCT06413862 | Not Yet Recruiting

• 1 other identifier: Ciprofol in hysteroscopy
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Painless Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Injection pain

  The injection pain was defined as the pain reported verbally by patients during the first injection of the investigational drugs (ciprofol or propofol). The Numerical Rating Scale (NRS) was used to evaluate the pain level. The anesthesiologist asks the patient during the first injection of the investigational drug (ciprofol or propofol), "Do you feel arm pain from the injection? Patients who answered "yes" was asked to describe the level of the pain (a score of 0 to 10 indicated "painless" to "unbearable pain"). The pain level was divided into painless (0 points), mild pain (1-3 points), and moderate to severe pain (4-10 points).

  24 hours within hysteroscopy

Secondary Outcomes (10)

• Sedation success rate

  24 hours within hysteroscopy

• Anesthesia success rate

  24 hours within hysteroscopy

• time for successful anesthesia induction

  24 hours within hysteroscopy

• recovery time

  24 hours within hysteroscopy

• use of rescue drugs

  24 hours within hysteroscopy

Study Arms (2)

Ciprofol group (ciprofol combined with alfentanil)

EXPERIMENTAL

Drug: Ciprofol

Propofol group (propofol combined with alfentanil)

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Ciprofol DRUG

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

Ciprofol group (ciprofol combined with alfentanil)

Propofol DRUG

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

Propofol group (propofol combined with alfentanil)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baoding First Central Hospital: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lei Zhu

  the First Central Hospital of Baoding

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhu

CONTACT

+86-13785214850; zhuleizlzl@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 14, 2024
• Study Start: August 10, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 10, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share