NCT05706337

Clinical Observation of Ciprofol for Anesthesia Induction

Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Xiumei Song · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

Detailed description

90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 \~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.

Conditions

• Anesthesia
• Pain
• Hemodynamic Instability

Interventions

Type	Name	Description
DRUG	Propofol	Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.
DRUG	Ciprofol	Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2023-01-31
• Last updated: 2023-01-31