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Not yet recruiting NCT06773351

A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

Phase IV Interventional Induction of General Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sevoflurane 0 + different doses of ciprofol, Sevoflurane 0.7% + different doses of ciprofol, Sevoflurane 1.0% + different doses of ciprofol 0.05, Sevoflurane 1.5% + differnet doses of ciprofol.
Who it may be relevant to
Registry conditions: Induction of General Anesthesia. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane During Anesthesia Induction

Overview

Intravenous and inhalation combined anesthesia is a commonly used method for maintaining general anesthesia in clinical practice. This study aims to explore the interaction between ciprofol and sevoflurane. By employing response surface methodology, we constructed a three-dimensional pharmacodynamic interaction surface for various dose combinations of ciprofol and sevoflurane. This approach allows us to determine the nature of the interaction between the two drugs at any given level, thereby providing a ciprofol understanding of the dose-response relationship when ciprofol and sevoflurane are used in combination. This knowledge will serve as a theoretical basis for rational drug administration during surgery.

Interventions

  • Drug Sevoflurane 0 + different doses of ciprofol
    Sevoflurane 0% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.6mg/kg, respectively.
  • Drug Sevoflurane 0.7% + different doses of ciprofol
    Sevoflurane 0.7% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.5mg/kg, respectively.
  • Drug Sevoflurane 1.0% + different doses of ciprofol 0.05
    Sevoflurane 1.0% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively.
  • Drug Sevoflurane 1.5% + differnet doses of ciprofol
    Sevoflurane 1.5% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively.
  • Drug Sevoflurane 2.0% + different doses of ciprofol
    Sevoflurane 2.0% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively.
  • Drug Sevoflurane 2.5% + different doses of ciprofol
    Sevoflurane 2.5% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively.
  • Drug Ciprofol 0 + different end-expiratory concentration of sevoflurane
    Ciprofol 0 combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5%, respectively.
  • Drug Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane
    Ciprofol 0.05 mg/kg combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5 %, respectively.
  • Drug Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane
    Ciprofol 0.1mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively.
  • Drug Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane
    Ciprofol 0.2 mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively.

Primary outcome measures

  • Bispectral Index (BIS) value [Time frame: Induction period of anesthesia]
  • The score of Observer's Assessment of Alertness/Sedation Scale [Time frame: Induction period of anesthesia]
  • Numbers of of participants with laryngoscopy and tracheal intubation positive response [Time frame: Induction period of anesthesia]
  • Numbers of participants with tracheal intubation stress positive respose [Time frame: Induction period of anesthesia]
  • Blood plasma concentration [Time frame: Induction period of anesthesia]
Secondary outcome measures (3)
  • HR [Time frame: Period of anesthesia]
  • MAP [Time frame: Period of anesthesia]
  • Adverse reactions [Time frame: Perioperative period]

Eligibility criteria

Inclusion criteria

  • Patients undergoing elective general anesthesia and non-cardiac surgery;
  • Age 18-60 years old, gender is not limited;
  • ASA I or II level;
  • Body mass index (BMI) 18-30 kg/m2

Exclusion criteria

  • Preoperative assessment of potential difficult airway risk;
  • Airway hyperreactivity;
  • There is disease of the central nervous system or cardiovascular system;
  • Currently using drugs that may alter the pharmacokinetics and pharmacokinetics of the drug under study;
  • Known or suspected allergy or contraindication to the components or regimens of the investigational drug;
  • A history of drug or alcohol addiction;
  • Patients with gastroesophageal reflux disease;
  • Severe liver and kidney dysfunction.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06773351 · TJ-IRB202412125 · S219

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗