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

Sponsor
Xijing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05843383
Collaborator
(none)
280
Enrollment
1
Location
2
Arms
18.8
Anticipated Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
participants were anesthetized and were unaware of the grouping. Care providers did not know the grouping. Specific investigators who did the intervention were aware of the grouping. The outcome assessors and the data analyzers did not know the grouping.
Primary Purpose:
Treatment
Official Title:
Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Gastrointestinal Surgery
Anticipated Study Start Date :
May 10, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1 [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)

    Secondary Outcome Measures

    1. Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2 [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)

    2. Incidence of injection pain [during anesthesia induction]

      Record the incidence of injection pain ( yes or no)

    3. Hemodynamic change [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

    4. Vasoactive agents [from start of surgery to end of surgery]

      Percentage of patients needed vasoactive agents during anesthesia

    5. Tracheal extubation time [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

    6. Postoperative sedation score [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

    7. Postoperative pain score [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)

    8. Postoperative nausea and vomiting [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)

    9. First exhaust time [24 hours after end of surgery, approximately 24 hours]

      Record the first exhaust time After the operation

    10. Hospital stay [From end of surgery to discharge from hospital, on an average of 7 days]

      days of hospital stay

    11. Postoperative complications [From end of surgery to discharge from hospital, on an average of 7 days]

      Various complications occurred during hospitalization

    12. Adverse event [From end of surgery to discharge from hospital, on an average of 7 days]

      Percentage of adverse events occurred during hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing elective gastrointestinal 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hospital Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xijing Hospital
    ClinicalTrials.gov Identifier:
    NCT05843383
    Other Study ID Numbers:
    • KY20222308-C-1
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xijing Hospital
    Ciprofol
    Propofol
    Additional relevant MeSH terms:
    Postoperative Complications
    Propofol

    Study Results

    No Results Posted as of May 6, 2023