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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Postoperative Complications; Postoperative Recovery; Anesthetics, Intravenous; Hypnotics and Sedatives

Treatments: Drug: Propofol; Drug: Ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05843383

KY20222308-C-1

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups

Ciprofol group

Experimental group

Description:

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

Treatment:

Drug: Ciprofol

Propofol group

Experimental group

Description:

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

Treatment:

Drug: Propofol