A Study on Median Effective Concentration of Ciprofol Combined With Remifentanil Via Target-controlled Infusion for Inhibiting Tracheal Intubation Stimulation Under qNOX Index Monitoring (EC50 via TCI)

April 14, 2026 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command
  1. The combined induction of intubation with propofol and remifentanil is widely used in clinical anesthesia, primarily through a single intravenous injection. Target-controlled infusion (TCI) technology, which combines pharmacology with clinical practice, offers a more stable and precise infusion mode;
  2. This project aims to explore the half-effective concentration (EC50) of propofol combined with remifentanil for inhibiting tracheal intubation stimulation through a sequential approach under the monitoring of qNOX pain index.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing elective surgery, aged 19 to 55 years, with ASA I or II, were selected for a sequential trial in two stages:

  1. In the first stage, induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 of remifentanil were measured.
  2. In the second stage, the EC95 of remifentanil was fixed, and the EC50 and EC95 of ciprofol were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method.
  3. Additionally, the effectiveness of the qNOX index in guiding tracheal intubation stimulation was evaluated by analyzing the receiver operating characteristic (ROC) curves.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The Third Affliated Hospital of Guangzhou Medical University

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients scheduled for elective surgery and require general anesthesia with single-lumen endotracheal intubation: ASA physical status I-II, aged between 18 and 55 years, with a body mass index (BMI) between 18.5 and 30 kg/m2

Exclusion Criteria:

  • 1.Emergency surgery patients, children, pregnant women; 2.Patients with unstable vital signs: such as blood pressure, heart rate, and blood oxygen saturation exceeding the safe range; 3.Patients with craniocerebral trauma or central nervous system lesions; 4.Patients who are allergic to the studied anesthetic drugs, or have recently received other experimental drugs, major surgery, radiotherapy, or chemotherapy; 5.Patients who refuse to sign the informed consent form.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stage 1
In the first stage, Induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 of remifentanil were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method.
Drug: Cipofol combined with remifentanil administered via target-controlled infusion
Cipofol combined with remifentanil administered via target-controlled infusion for inhibiting tracheal intubation stimulation in adults under qNOX pain index monitoring.
Other: Stage 2
In the second stage, the EC95 of remifentanil was fixed, and the EC50 and EC95 of ciprofol were measured. The EC and 95% confidence interval (CI) were calculated using the probit probability unit method.
Drug: Cipofol combined with remifentanil administered via target-controlled infusion
Cipofol combined with remifentanil administered via target-controlled infusion for inhibiting tracheal intubation stimulation in adults under qNOX pain index monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Half-effective concentration
Time Frame: Calculated using SPSS software based on the TCI target concentration set during anesthesia induction (the fixed value of the inducing dose does not change over time).
Calculated using SPSS software based on the TCI target concentration set during anesthesia induction (the fixed value of the inducing dose does not change over time).
Heart rate
Time Frame: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
blood pressure
Time Frame: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
CCS score (intubation score)
Time Frame: within 1 min while intubation (satisfactory intubation conditions simultaneously meet: visible laryngoscope exposure, no vocal cord movement, no coughing, relaxed jaw, no limb movement; otherwise, it is considered unsatisfactory intubation conditions)
within 1 min while intubation (satisfactory intubation conditions simultaneously meet: visible laryngoscope exposure, no vocal cord movement, no coughing, relaxed jaw, no limb movement; otherwise, it is considered unsatisfactory intubation conditions)

Secondary Outcome Measures

Outcome Measure
Time Frame
BIS index
Time Frame: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
qNOX index
Time Frame: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
EMG index
Time Frame: 5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).
5 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).

Collaborators and Investigators

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

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

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)

March 3, 2026

Primary Completion (Actual)

April 3, 2026

Study Completion (Actual)

April 6, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Median effective concentration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

for privacy protection

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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