AzTrials
AzTrials

Elective SurgeryEC50 via TCINCT07462949

EC50 of Ciprofol Combined With Remifentanil for Inhibiting Tracheal Responses in Patients Undergoing Gynecological Surgery: a Two-phase Up-and-down Sequential Allocation Study

A study of Elective Surgery and Target Controlled Infusion (TCI), run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 55 years
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
3 Mar 2026to 6 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Third Affliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

  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.
Read the 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 (exploratory) of remifentanil were measured.
  2. In the second stage, the concentration of remifentanil was fixed, and the EC50 and EC95 (exploratory) 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.
Being tested
Cipofol combined with remifentanil administered via target-controlled infusion
Keywords
ciprofol, remifentanil, effective concentration, tracheal intubation stimulation, qNOX index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cipofol combined with remifentanil administered via target-controlled infusionDrug

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

Study groups in NCT07462949
Study groupRoleWhat they receive
Stage 1OtherIn 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.
Receives: Drug: Cipofol combined with remifentanil administered via target-controlled infusion
Stage 2OtherIn the second stage, the concentration 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.
Receives: Drug: Cipofol combined with remifentanil administered via target-controlled infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Half-effective concentration

    Measured: 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

    Measured: 1 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

    Measured: 1 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)

    Measured: 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)

  1. BIS index

    Measured: 1 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

    Measured: 1 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

    Measured: 1 min before intubation, during intubation (within 1~1.5 min) and 5 min after intubation (take the average of three measurements at each stage).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start3 Mar 2026
  3. Primary completion3 Apr 2026
  4. Study completion6 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential method: Adjust the drug concentration for the next patient based on whether the previous case meets the conditions for inhibiting intubation stimulation
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07462949
Sponsor's protocol ID
Median effective concentration
Acronym
EC50 via TCI
Status last verified
Aug 2026
First submitted
3 Mar 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: for privacy protection

Publications

  • 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.

  • 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.

    PubMed 40683805

  • 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.

    PubMed 36618929

  • 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.

    PubMed 34559359

  • 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.

    PubMed 35035718

  • 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.

    PubMed 39758227

  • 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.

    PubMed 40220354

  • 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.

    PubMed 16492836

  • 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.

    PubMed 31047645

Questions about this trial

What is this clinical trial studying?

A study of Elective Surgery and Target Controlled Infusion (TCI), run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07462949, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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