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

NCT07462949 | Completed DMC

• 1 other identifier: Median effective concentration
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

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

Keywords

ciprofol; remifentanil; effective concentration; tracheal intubation stimulation; qNOX index

Outcome Measures

Primary Outcomes (4)

• Half-effective concentration

  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

  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

  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)

  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 (3)

• BIS index

  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

  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

  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).

Study Arms (2)

Stage 1

OTHER

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

Stage 2

OTHER

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

Interventions

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.

Stage 1; Stage 2

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou General Hospital of Guangzhou Military Command: lead

Study Sites (1)

The Third Affliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (9)

• 洪桂平. 环泊酚靶控输注在口腔癌根治术中的应用[D]. 中南大学, 2023.

  BACKGROUND

• Schuller PJ, Pretorius JPG, Newbery KB. Response of the Conox quantitative electroencephalographic monitor to neuromuscular block in awake volunteers. Br J Anaesth. 2025 Sep;135(3):660-667. doi: 10.1016/j.bja.2025.05.023. Epub 2025 Jul 18.

  PMID: 40683805 BACKGROUND

• Wu B, Zhu W, Wang Q, Ren C, Wang L, Xie G. Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial. Front Pharmacol. 2022 Dec 21;13:1091579. doi: 10.3389/fphar.2022.1091579. eCollection 2022.

  PMID: 36618929 BACKGROUND

• Hu C, Ou X, Teng Y, Shu S, Wang Y, Zhu X, Kang Y, Miao J. Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial. Adv Ther. 2021 Nov;38(11):5484-5500. doi: 10.1007/s12325-021-01914-4. Epub 2021 Sep 24.

  PMID: 34559359 BACKGROUND

• Teng Y, Ou MC, Wang X, Zhang WS, Liu X, Liang Y, Zuo YX, Zhu T, Liu B, Liu J. Pharmacokinetic and pharmacodynamic properties of ciprofol emulsion in Chinese subjects: a single center, open-label, single-arm dose-escalation phase 1 study. Am J Transl Res. 2021 Dec 15;13(12):13791-13802. eCollection 2021.

  PMID: 35035718 BACKGROUND

• Lan H, Liu S, Liao Y, Xu B, Lin Y, Wu X, Chen Q, Chen H, Guan X. EC50 and EC95 of Remifentanil for Inhibiting Bronchoscopy Responses in Elderly Patients During Fiberoptic Bronchoscopy Under Ciprofol Sedation: An Up-and-Down Sequential Allocation Trial. Drug Des Devel Ther. 2024 Dec 31;18:6487-6497. doi: 10.2147/DDDT.S490907. eCollection 2024.

  PMID: 39758227 BACKGROUND

• Vide S, Kreuzer M, Ferreira A, Couto M, Agusti M, Jaramillo S, Schneider G, Garcia PS, Abelha F, Amorim P, Troconiz I, Larson M, Gambus P. Cortical, subcortical, brainstem and autonomic responses to nociception under total intravenous anesthesia. J Clin Anesth. 2025 Apr;103:111825. doi: 10.1016/j.jclinane.2025.111825. Epub 2025 Apr 12.

  PMID: 40220354 BACKGROUND

• Kox WJ, von Heymann C, Heinze J, Prichep LS, John ER, Rundshagen I. Electroencephalographic mapping during routine clinical practice: cortical arousal during tracheal intubation? Anesth Analg. 2006 Mar;102(3):825-31. doi: 10.1213/01.ane.0000197776.26307.fa.

  PMID: 16492836 BACKGROUND

• Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.

  PMID: 31047645 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Sequential method: Adjust the drug concentration for the next patient based on whether the previous case meets the conditions for inhibiting intubation stimulation

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 10, 2026
• Study Start: March 3, 2026
• Primary Completion: April 3, 2026
• Study Completion: April 6, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)