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Completed

NCT Number: NCT07148596

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

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.

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Key information

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Ciprofol dosage

    Time frame: During anesthetic Induction

    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).

  2. Bispectral index

    Time frame: Baseline (Before surgery)

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

Secondary outcomes

  1. Mean arterial pressure (MAP)

    Time frame: up to 3 minutes

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

  2. heart rate (HR)

    Time frame: up to 3 minutes

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

  3. SpO₂

    Time frame: up to 3 minutes

    SpO₂ before infusion, at loss of consciousness, and at 1 and 3 minutes post-loss.

  4. Incidence of adverse reactions including respiratory depression and injection pain

    Time frame: Baseline (Before surgery)

    Respiratory depression was defined as meeting any of the following criteria: respiratory rate <10 breaths/min, arterial oxygen saturation <90%, arterial partial pressure of carbon dioxide (PaCO₂) ≥50 mmHg, or apnea lasting ≥15 seconds. Injection pain is a subjective discomfort experienced by conscious patients during ciprofol infusion, diagnosed based on clinical manifestations and patient-reported complaints.

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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