Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery

April 6, 2024 updated by: Xijing Hospital

Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Laparoscopic Surgery

Ciprofol is a novel 2,6-disubstituted phenol derivatives and is proved have much higher potency and tighter binding toward ɣ-aminobutyric acid type A (GABAA) receptor while maintaining a fast on-set and recovery time compared to propofol. Except lower incidence of hypotension and respiratory depression, it has no injection pain and infusion syndrome compared with propofol. There is no study to investigate overall postoperative functional recovery in patients receiving total intravenous anesthesia (TIVA) using ciprofol yet. However, according to study, early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. Therefore, the purpose of this study is to determine whether there is any difference in the quality of postoperative recovery between ciprofol-based and propofol-based TIVA in elderly patients undergoing gastrointestinal surgery. The QoR-15 questionnaire score, pain, nausea/vomiting, and the frequency of complications are evaluated and compared between the two groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.
280

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.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Xijing Hospital
        • Contact:
          • Wanwan Yang
      • Xi'an, Shaanxi, China, 710032
        • Not yet recruiting
        • Xijing Hospital
        • Contact:
        • Principal Investigator:
          • Haopeng Zhang
        • Sub-Investigator:
          • Wanwan Yang

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:

  • Patients undergoing elective laparoscopic surgery under endotracheal intubation and general anesthesia
  • American Society of Anesthesiologists (ASA) classification: I to III;
  • Age ≥ 60 years, BMI < 30 kg/m2;
  • Unconscious speech audiovisual impairment or unable to cooperate;
  • Informed consent has been signed.

Exclusion Criteria:

  • Taking any sedative, opioid, or sleep aid drugs;
  • Psychiatric or neurological disorder;
  • Allergic to ciprofol, propofol or soy, or a family history of malignant hyperthermia;
  • Severe liver and kidney dysfunction;
  • Operation duration < 2 hours;
  • Plan to the intensive care unit with tracheal catheter;
  • Have participated in this study or other clinical studies.

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: Triple

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-based total intravenous anesthesia is given for maintenance of general anesthesia
Drug: Ciprofol
Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil
Other Names:
  • HSK3486
Experimental: Propofol group
Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Drug: Propofol
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil
Other Names:
  • 2,6-diisopropylphenol

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
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
Time Frame: Postoperative day 1
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1(minimum value: 0, maximum value: 150, the higher the score, the better the result)
Postoperative day 1

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
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2
Time Frame: Postoperative day 2
Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2 (minimum value: 0, maximum value: 150, the higher the score, the better the result)
Postoperative day 2
Incidence of injection pain
Time Frame: during anesthesia induction
Record the incidence of injection pain ( yes or no)
during anesthesia induction
Hemodynamic change
Time Frame: During the operation
Record the mean arterial pressure (MAP) at different points, including before induction, after induction, immediately after intubation, at the beginning of surgery, at the end of anesthesia, immediately after extubation, and before leaving the room
During the operation
Vasoactive agents
Time Frame: from start of surgery to end of surgery
Percentage of patients needed vasoactive agents during anesthesia
from start of surgery to end of surgery
Tracheal extubation time
Time Frame: From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes
Time from cessation of main anaesthetics to tracheal extubation
From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes
Postoperative sedation score
Time Frame: Immediately after awake，approximately 1 hour after surgery
Monitored by the sedation scale called Sedation-Agitation Scale (SAS). SAS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from 1 to 7
Immediately after awake，approximately 1 hour after surgery
Postoperative pain score
Time Frame: Immediately after awake, approximately 1 hour after surgery
postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain)
Immediately after awake, approximately 1 hour after surgery
Postoperative nausea and vomiting
Time Frame: Immediately after awake, approximately 1 hour after surgery
Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4)
Immediately after awake, approximately 1 hour after surgery
First exhaust time
Time Frame: 24 hours after end of surgery, approximately 24 hours
Record the first exhaust time After the operation
24 hours after end of surgery, approximately 24 hours
Hospital stay
Time Frame: From end of surgery to discharge from hospital, on an average of 7 days
days of hospital stay
From end of surgery to discharge from hospital, on an average of 7 days
Postoperative complications
Time Frame: From end of surgery to discharge from hospital, on an average of 7 days
Various complications occurred during hospitalization
From end of surgery to discharge from hospital, on an average of 7 days
Adverse event
Time Frame: From end of surgery to discharge from hospital, on an average of 7 days
Percentage of adverse events occurred during hospitalization
From end of surgery to discharge from hospital, on an average of 7 days

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.
Xijing 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.
  • Study Chair: Haopeng Zhang, Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
May 16, 2023

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 1, 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.
December 1, 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).
April 3, 2023

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.
April 24, 2023

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 6, 2023

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.
April 9, 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.
April 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.
May 1, 2023

More Information

Terms related to this study

Keywords

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.
  • KY20222308-C-1

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings