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

General Hospital of Ningxia Medical University

Status: Not yet enrolling

Conditions: Ciprofol

Treatments: Other: It is an observational study without any intervention measures.

Study type: Observational

Funder types: Other

Identifiers

NCT07148596

Yue Wen-2025-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 3+ years old

Volunteers: Accepts Healthy Volunteers

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