Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

August 6, 2024 updated by: Lei Zhu, Baoding First Central Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Injection pain
Time Frame: 24 hours within hysteroscopy
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sedation success rate
Time Frame: 24 hours within hysteroscopy
No more than 5 supplementary doses within 15 minutes
24 hours within hysteroscopy
Anesthesia success rate
Time Frame: 24 hours within hysteroscopy
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
Time Frame: 24 hours within hysteroscopy
the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1
24 hours within hysteroscopy
recovery time
Time Frame: 24 hours within hysteroscopy
the time from the last administration of investigational drugs to awaken
24 hours within hysteroscopy
use of rescue drugs
Time Frame: 24 hours within hysteroscopy
ephedrine, atropine
24 hours within hysteroscopy
times of supplementing ciprofol or propofol
Time Frame: 24 hours within hysteroscopy
times of supplementing ciprofol or propofol
24 hours within hysteroscopy
adverse events
Time Frame: 24 hours within hysteroscopy
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
Time Frame: 24 hours within hysteroscopy
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
Time Frame: 24 hours within hysteroscopy
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
Time Frame: 24 hours within hysteroscopy
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baoding First Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lei Zhu, the First Central Hospital of Baoding

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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