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

Primary Purpose

Anesthetics, Intravenous, Postoperative Complications, Hypnotics and Sedatives

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ciprofol
Propofol
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthetics, Intravenous focused on measuring Ciprofol, Propofol

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hospital
  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ciprofol group

Propofol group

Arm Description

Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia

Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia

Outcomes

Primary Outcome Measures

Quality of Recovery(QoR)-15 questionnaire score at 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

Quality of Recovery(QoR)-15 questionnaire score at 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)
Incidence of injection pain
Record the incidence of injection pain ( yes or no)
Hemodynamic change
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
Vasoactive agents
Percentage of patients needed vasoactive agents during anesthesia
Tracheal extubation time
Time from cessation of main anaesthetics to tracheal extubation
Postoperative sedation score
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
Postoperative pain score
postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain)
Postoperative nausea and vomiting
Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4)
First exhaust time
Record the first exhaust time After the operation
Hospital stay
days of hospital stay
Postoperative complications
Various complications occurred during hospitalization
Adverse event
Percentage of adverse events occurred during hospitalization

Full Information

First Posted
April 3, 2023
Last Updated
July 17, 2023
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05843383
Brief Title
Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery
Official Title
Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery in Elderly Patients Undergoing Gastrointestinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthetics, Intravenous, Postoperative Complications, Hypnotics and Sedatives, Postoperative Recovery
Keywords
Ciprofol, Propofol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ciprofol group
Arm Type
Experimental
Arm Description
Ciprofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Arm Title
Propofol group
Arm Type
Experimental
Arm Description
Propofol-based total intravenous anesthesia is given for maintenance of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Ciprofol
Other Intervention Name(s)
HSK3486
Intervention Description
Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
2,6-diisopropylphenol
Intervention Description
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil
Primary Outcome Measure Information:
Title
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
Description
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)
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 2
Description
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)
Time Frame
Postoperative day 2
Title
Incidence of injection pain
Description
Record the incidence of injection pain ( yes or no)
Time Frame
during anesthesia induction
Title
Hemodynamic change
Description
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
Time Frame
During the operation
Title
Vasoactive agents
Description
Percentage of patients needed vasoactive agents during anesthesia
Time Frame
from start of surgery to end of surgery
Title
Tracheal extubation time
Description
Time from cessation of main anaesthetics to tracheal extubation
Time Frame
From stopping ciprofol or propofol infusion to awake and withdrawal of tracheal tube, approximately 30 minutes
Title
Postoperative sedation score
Description
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
Time Frame
Immediately after awake,approximately 1 hour after surgery
Title
Postoperative pain score
Description
postoperative pain score measured by 11-point VAS (Visual Analogue Scale) score (minimum : 0, maximum : 10, the lower the score, the lesser pain)
Time Frame
Immediately after awake, approximately 1 hour after surgery
Title
Postoperative nausea and vomiting
Description
Postoperative nausea and vomiting will be evaluated by PONV (Post Operative Nausea And Vomiting) score (no : 0, vomit: 4)
Time Frame
Immediately after awake, approximately 1 hour after surgery
Title
First exhaust time
Description
Record the first exhaust time After the operation
Time Frame
24 hours after end of surgery, approximately 24 hours
Title
Hospital stay
Description
days of hospital stay
Time Frame
From end of surgery to discharge from hospital, on an average of 7 days
Title
Postoperative complications
Description
Various complications occurred during hospitalization
Time Frame
From end of surgery to discharge from hospital, on an average of 7 days
Title
Adverse event
Description
Percentage of adverse events occurred during hospitalization
Time Frame
From end of surgery to discharge from hospital, on an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanwan Yang
Phone
029-84775343
Email
yangwanwan2017@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haopeng Zhang
Phone
029-84775343
Email
haopeng.zhang@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haopeng Zhang
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanwan Yang
Phone
029-84775343
Email
yangwanwan2017@163.com
First Name & Middle Initial & Last Name & Degree
Haopeng Zhang
First Name & Middle Initial & Last Name & Degree
Wanwan Yang
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanwan Yang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28430430
Citation
Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
Results Reference
background
PubMed Identifier
32415708
Citation
Bian Y, Zhang H, Ma S, Jiao Y, Yan P, Liu X, Ma S, Xiong Y, Gu Z, Yu Z, Huang C, Miao L. Mass balance, pharmacokinetics and pharmacodynamics of intravenous HSK3486, a novel anaesthetic, administered to healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):93-105. doi: 10.1111/bcp.14363. Epub 2020 Aug 3.
Results Reference
background
PubMed Identifier
33896305
Citation
Bakhtiari E, Mousavi SH, Gharavi Fard M. Pharmacological control of pain during propofol injection: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2021 Jul;14(7):889-899. doi: 10.1080/17512433.2021.1919084. Epub 2021 Jun 1.
Results Reference
background
PubMed Identifier
21406529
Citation
Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.
Results Reference
background
PubMed Identifier
35157236
Citation
Luo Z, Tu H, Zhang X, Wang X, Ouyang W, Wei X, Zou X, Zhu Z, Li Y, Shangguan W, Wu H, Wang Y, Guo Q. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14.
Results Reference
background
PubMed Identifier
35033845
Citation
Campfort M, Cayla C, Lasocki S, Rineau E, Leger M. Early quality of recovery according to QoR-15 score is associated with one-month postoperative complications after elective surgery. J Clin Anesth. 2022 Jun;78:110638. doi: 10.1016/j.jclinane.2021.110638. Epub 2022 Jan 13.
Results Reference
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Comparison of Ciprofol-based and Propofol-based Total Intravenous Anesthesia on Postoperative Quality of Recovery

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