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NCT Number: NCT07462949

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

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.

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Key information

Conditions

Elective Surgery Noxious Stimuli Target Controlled Infusion (TCI) Tracheal Intubation Stimulation

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

About this study

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

  • In the first stage, induction dose of ciprofol was fixed at 0.4 mg/kg, and the EC50 and EC95 of remifentanil were measured.
  • 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.
  • Additionally, the effectiveness of the qNOX index in guiding tracheal intubation stimulation was evaluated by analyzing the receiver operating characteristic (ROC) curves.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Cipofol combined with remifentanil administered via target-controlled infusion

Drug

Cipofol combined with remifentanil administered via target-controlled infusion for inhibiting tracheal intubation stimulation in adults under qNOX pain index monitoring.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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)

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Registry information

Acronym: EC50 via TCI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Apr 17, 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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