A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

Feng Gao

Status and phase: Not yet enrolling; Phase 4

Conditions: Induction of General Anesthesia

Treatments: Drug: Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0 + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevoflurane; Drug: Sevoflurane 2.5% + different doses of ciprofol; Drug: Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane; Drug: Sevoflurane 1.0% + different doses of ciprofol 0.05; Drug: Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane; Drug: Sevoflurane 0 + different doses of ciprofol; Drug: Sevoflurane 1.5% + differnet doses of ciprofol; Drug: Sevoflurane 0.7% + different doses of ciprofol; Drug: Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevoflurane; Drug: Sevoflurane 2.0% + different doses of ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06773351

S219 (Other Grant/Funding Number)

TJ-IRB202412125

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

sevoflurane group

Experimental group

Description:

Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%

Treatment:

Drug: Sevoflurane 1.0% + different doses of ciprofol 0.05

Drug: Sevoflurane 2.0% + different doses of ciprofol

Drug: Sevoflurane 1.5% + differnet doses of ciprofol

Drug: Sevoflurane 0.7% + different doses of ciprofol

Drug: Sevoflurane 0 + different doses of ciprofol

Drug: Sevoflurane 2.5% + different doses of ciprofol

ciprofol group

Experimental group

Description:

The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg

Treatment:

Drug: Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane

Drug: Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevoflurane

Drug: Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevoflurane

Drug: Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane

Drug: Ciprofol 0 + different end-expiratory concentration of sevoflurane

Drug: Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane