NCT07148596

Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages

Changes of Ciprofol Dosage and Bispectral Index Required for Loss of Consciousness in Patients of Different Ages: a Single-center, Prospective, Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: General Hospital of Ningxia Medical University · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

This study aims to explore dose requirements for loss of consciousness and bispectral index changes during general anesthesia induction with ciprofol in patients of different ages, providing a reference for its rational clinical application.

Detailed description

Ciprofol, a novel gamma-aminobutyric acid (GABA) receptor agonist, is structurally modified from propofol by adding a cyclopropyl group to its side chain, forming an R-type chiral structure. This modification enhances its affinity for GABA receptors, resulting in faster onset, rapid metabolism, higher potency, reduced injection pain, and milder respiratory/circulatory suppression. Ciprofol exhibits good safety and tolerability, smooth and rapid induction, complete recovery, and low incidence of injection pain, making it a promising alternative to propofol. Age is a critical factor influencing general anesthesia and anesthetic drug responses. Age-related changes in organ function affect pharmacokinetics and pharmacodynamics, leading to variations in required drug doses and characteristic electroencephalogram changes. Therefore, this study aims to compare ciprofol doses and BIS changes during general anesthesia induction across age groups, offering reference and guidance for clinical medication.

Conditions

• Ciprofol

Interventions

Type	Name	Description
OTHER	It is an observational study without any intervention measures.	All patients will fast for 6 hours and will abstain from drinking for 2 hours preoperatively, with no premedication. Preoxygenation will be performed with an oxygen flow rate of 6 L/min. Ciprofol will be continuously infused via a micropump at a rate of 12 mg/kg/h. During preoxygenation with a facemask, if respiratory depression occurs during ciprofol infusion, assisted ventilation via facemask will be initiated. After LOC and completion of observation indices, the anesthesiologist may administer midazolam (1-3 mg), sufentanil (0.2-0.5 μg/kg), and rocuronium (0.3-0.6 mg/kg) sequentially based on the patient's age, physical condition, and BIS values to complete anesthesia induction. If hypotension (systolic blood pressure \<90 mmHg or \<80% of baseline) or bradycardia (heart rate \<50 beats/min) occurs during induction, vasoactive agents such as ephedrine or atropine will be administered for management.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-07
• First posted: 2025-08-29
• Last updated: 2026-03-03

Locations

1 site across 1 country: China