The Effective Blood Concentration of Ciprofol

January 5, 2026 updated by: Peking University Shenzhen Hospital

Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study

  1. Eligible patients were selected and enrolled in the study.
  2. General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction.
  3. The patients' pain and cognition are followed up after surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective thyroidectomy at Peking University Shenzhen Hospital

Description

Inclusion Criteria:

  • Patients aged 18-65 years
  • Scheduled for elective thyroidectomy
  • ASA physical status classification I-II
  • Willing to participate and providing written informed consent

Exclusion Criteria:

  • Recent use of sedatives or opioid analgesics
  • Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance <35 mL/min ,Requiring preoperative dialysis
  • Significant cardiovascular comorbidities
  • Body mass index ≥35 kg/m² or <18.5 kg/m²
  • Known hypersensitivity or adverse reactions to propofol/ciprofol
  • Neuropsychiatric disorders including:Alzheimer's disease,History of cerebrovascular events,Traumatic brain injury,Space-occupying brain lesions,Other significant neurological deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ciprofol group
Anesthesia induction was achieved through target-controlled infusion of ciprofol.
Drug: Ciprofol
Beginning with an initial target plasma concentration of ciprofol at 1.2 μg/mL. Assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale and Bispectral Index (BIS) values are performed every minute until the patient achieves a complete anesthetic state (defined as an MOAA/S score of 0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect-site concentration of cipofol, when MOAAS reaches 2
Time Frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).

The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 2.

(Modified Observer's Assessment of Alertness/Sedation: 5--Responds readily to name spoken in normal tone ； 4--Lethargic response to name spoken in normal tone ； 3--Responds only after name is called loudly and/or repeatedly ； 2--Responds only after mild prodding or shaking ；

1--Responds only after painful trapezius squeeze ； 0--No response after painful trapezius squeeze；)
From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect-site concentration of cipofol, when MOAA/S reaches 0.
Time Frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
The effect-site concentration of cipofol corresponding to MOAA/S score (Modified Observer's Assessment of Alertness/Sedation) of 0.
From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
Bispectral index
Time Frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values.
Bispectral Index (BIS) values corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.
From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the BIS values.
The EC₅₀ and EC₉₅ of ciprofol
Time Frame: From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
The EC₅₀ and EC₉₅ of ciprofol corresponding to MOAA/S scores of 2 and 0
From the beginning of anesthesia induction until 1 minute after intubation , the MOAA/S score was assessed every minute, with simultaneous recording of the effect-site concentration (Ce).
Heart rate
Time Frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR.
Heart rate(in bpm) corresponding to different Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores.
From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the HR.
Blood pressure
Time Frame: From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure.
The systolic blood pressure, diastolic blood pressure and mean arterial pressure corresponding to different MOAAS scores were all recorded.
From the beginning of anesthesia induction until 1 minute after intubation, the MOAA/S score was assessed every minute, with simultaneous recording of the systolic blood pressure, diastolic blood pressure and mean arterial pressure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Shenzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Estimated)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-117 (Other Identifier: PRMC Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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