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

NCT ID: NCT07148596

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-20

Brief 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

Keywords

Bispectral index; Different ages; Loss of consciousness

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1) The ASA classification I-II 2) BMI range: 18.5 < BMI ≤ 24.9 kg/m² 3) Scheduled for elective general anesthesia surgery 4) Signed informed consent by the patient or legal guardian

Exclusion Criteria

• 1) Patients with central nervous system disorders or using medications affecting the central nervous system 2) Patients with cardiac, hepatic, pulmonary, or renal dysfunction 3) History of alcohol or drug abuse 4) Allergy to the study drug 5) Patients with hematologic or metabolic diseases 6) Participation in other drug clinical trials within the past 4 weeks 7) Refusal to participate in the study

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Countries

China

Central Contacts

Ma Hanxiang

Role: CONTACT

Phone: 86-13519591508

Email: mahanxiang@hotmail.com

Facility Contacts

Ma Hanxiang

Role: primary

Other Identifiers

Yue Wen-2025-04

Identifier Type: -

Identifier Source: org_study_id