Clinical trial

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

Name
KY20222308-C-1
Description
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.
Trial arms
Trial start
2023-05-16
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Ciprofol
Ciprofol group will be started and maintained total intravenous anesthesia with ciprofol and remifentanil
Arms:
Ciprofol group
Other names:
HSK3486
Propofol
Propofol group will be started and maintained total intravenous anesthesia with propofol and remifentanil
Arms:
Propofol group
Other names:
2,6-diisopropylphenol
Size
280
Primary endpoint
Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1
Postoperative day 1
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

2 products

5 indications

Organization
Xijing Hospital
Product
Ciprofol
Indication
Anesthetics
Indication
Intravenous
Product
Propofol