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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Xijing Hospital

Investigators

  • 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)

May 16, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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