Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy

July 30, 2024 updated by: Anhui Provincial Hospital

Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy: a Study Protocol for a Single-center, Double-blind, Randomized Controlled Trial

Both ciprofol and remimazolam have been found to be potential alternatives to propofol (a commonly used anesthesia) during fiberoptic bronchoscopy, while the efficacy and safety between ciprofol and remimazolam have not been reported. This study aims to compare the efficacy and safety between ciprofol and remimazolam in patients undergoing fiberoptic bronchoscopy.

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.

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.
190

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

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. male or female patients with age ≥ 18 years old;
  2. scheduled to undergo bronchoscopy under laryngeal mask airway;
  3. with American Society of Anesthesiologists (ASA) physical status classes II to Ⅲ; and
  4. volunteering to participate in this study and signing an informed consent form.

Exclusion Criteria:

  1. with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents;
  2. allergic to eggs, bean products, or experimental drugs (ciprofol, sufentanil, or remimazolam);
  3. difficult airway;
  4. with bradycardia or other serious cardiovascular diseases;
  5. with severe damages or diseases in important organs such as the lungs, brain, liver, or kidneys;
  6. using sedatives or antidepressants for a long time;
  7. pregnant or lactating women; and (8) unable to communicate or cooperate.

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
Drug: Ciprofol
Participants in the ciprofol group will be intravenously injected with 0.4 mg/kg of ciprofol (batch number H20200013, Haisike Pharmaceutical Co., Ltd., Liaoning, China) and sufentanil (0.2 μg/kg).
Active Comparator: Remimazolam group
Drug: Remimazolam
Participants in the remimazolam group will be intravenously injected with 0.1 mg/kg of remimazolam besylate (batch number HR7056, Hengrui Pharmaceutical Co., Ltd., Jiangsu, China) and sufentanil (0.2 μg/kg).

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
Time Frame
The success rate of fiberoptic bronchoscopy
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy

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
Induction time
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Procedure time
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Awake time
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Recovery time
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Stay time in PACU
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Supplemental times of experimental drugs (ciprofol or remimazolam)
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Doses of experimental drugs (ciprofol or remimazolam)
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Times of using rescue sedative drug
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Doses of using rescue sedative drug
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Incidence of adverse events
Time Frame: 24 hours after fiberoptic bronchoscopy
24 hours after fiberoptic bronchoscopy
Patients' satisfaction
Time Frame: 24 hours after fiberoptic bronchoscopy
Patients' satisfaction is assessed using the Satisfaction Scale reported by Luo et al. The Satisfaction Scale ranges from 0 to 10 points and contains five items. The higher score indicates better satisfaction.
24 hours after fiberoptic bronchoscopy
Heart rate
Time Frame: 6 minutes after fiberoptic bronchoscopy
6 minutes after fiberoptic bronchoscopy
SBP
Time Frame: 6 minutes after fiberoptic bronchoscopy
6 minutes after fiberoptic bronchoscopy
Diastolic blood pressure
Time Frame: 6 minutes after fiberoptic bronchoscopy
6 minutes after fiberoptic bronchoscopy
SpO2
Time Frame: 6 minutes after fiberoptic bronchoscopy
6 minutes after fiberoptic bronchoscopy

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.
Anhui Provincial Hospital

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.
December 1, 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.
December 30, 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.
March 31, 2025

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 21, 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.
July 30, 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.
August 1, 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 1, 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.
July 30, 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.
May 1, 2024

More Information

Terms related to this study

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.
  • Fiberoptic bronchoscopy

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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