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

NCT07148596 | Completed DMC

• 1 other identifier: Yue Wen-2025-04
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Ciprofol

Keywords

Bispectral index; Different ages; Loss of consciousness

Outcome Measures

Primary Outcomes (2)

• Ciprofol dosage

  Ciprofol dose required to achieve loss of consciousness. Ciprofol was continuously infused via a micropump at a rate of 12 mg/kg/h. The Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and loss of eyelash reflex were used to assess sedation depth, with evaluations performed every 5 seconds. A MOAA/S score ≤1 and loss of eyelash reflex were defined as loss of consciousness (LOC).

  During anesthetic Induction

• Bispectral index

  Bispectral index before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.

  Baseline (Before surgery)

Secondary Outcomes (4)

• Mean arterial pressure (MAP)

  up to 3 minutes

• heart rate (HR)

  up to 3 minutes

• SpO₂

  up to 3 minutes

• Incidence of adverse reactions including respiratory depression and injection pain

  Baseline (Before surgery)

Interventions

It is an observational study without any intervention measures. OTHER

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.

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 120 patients scheduled for general anesthesia were selected according to inclusion/exclusion criteria, with balanced age distribution and equal gender allocation (60 males and 60 females).

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

MeSH Terms

Conditions

Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: August 29, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 7, 2025
• Last Updated: March 3, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)