Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Painless Hysteroscopy
• Intervention / Treatment: Drug: Ciprofol; Drug: Propofol

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.

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Zhu; Phone Number: +86-13785214850; Email: zhuleizlzl@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol group (ciprofol combined with alfentanil)	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).
Active Comparator: Propofol group (propofol combined with alfentanil)	Drug: Propofol; The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation success rate	No more than 5 supplementary doses within 15 minutes	24 hours within hysteroscopy
Anesthesia success rate	the absence of any alternative sedatives/anesthetic drugs after the initial administration of the investigational drugs	24 hours within hysteroscopy
time for successful anesthesia induction	the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1	24 hours within hysteroscopy
recovery time	the time from the last administration of investigational drugs to awaken	24 hours within hysteroscopy
use of rescue drugs	ephedrine, atropine	24 hours within hysteroscopy
times of supplementing ciprofol or propofol	times of supplementing ciprofol or propofol	24 hours within hysteroscopy
adverse events	nausea, vomiting, hypoxemia (blood oxygen saturation < 90% and lasting > 30 seconds), bradycardia (heart rate < 55 beats/minute), hypotension (systolic blood pressure reduced by 20% compared to baseline), body movement (patient's unconscious limb movements) during the examination	24 hours within hysteroscopy
severity level of adverse events	graded based the National Cancer Institute Common Terminology Criteria for the Classification of Adverse Events (CTCAE) version 5.0, and divided into grade 1 (mild), grade 2 (moderate), grade 3 (severe or medically significant but not immediately life threatening), grade 4 (events with life-threatening consequences needing urgent intervention), grade 5 (death related to the adverse events)	24 hours within hysteroscopy
patient satisfaction	using a 10-point scale, with 1 point indicating extreme dissatisfaction and 10 points indicating very satisfied	24 hours within hysteroscopy
comparison of vital signs before and after administration	The systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, blood oxygen saturation in %, and heart rate in bpm were recorded before anesthesia induction (T0), after anesthesia induction (T1), at cervical dilation (T2), and at consciousness recovery (T3)	24 hours within hysteroscopy

Collaborators and Investigators

• Sponsor: Baoding First Central Hospital
• Investigators: Principal Investigator: Lei Zhu, the First Central Hospital of Baoding

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): June 9, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: Ciprofol in hysteroscopy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No