A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Induction of General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sevoflurane group

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

Group Type EXPERIMENTAL

Sevoflurane 0 + different doses of ciprofol

Intervention Type DRUG

Sevoflurane 0% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.6mg/kg, respectively.

Sevoflurane 0.7% + different doses of ciprofol

Intervention Type DRUG

Sevoflurane 0.7% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.5mg/kg, respectively.

Sevoflurane 1.0% + different doses of ciprofol 0.05

Intervention Type DRUG

Sevoflurane 1.0% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively.

Sevoflurane 1.5% + differnet doses of ciprofol

Intervention Type DRUG

Sevoflurane 1.5% combined with ciprofol 0.05, 0.1, 0.2, 0.3, 0.4mg/kg, respectively.

Sevoflurane 2.0% + different doses of ciprofol

Intervention Type DRUG

Sevoflurane 2.0% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively.

Sevoflurane 2.5% + different doses of ciprofol

Intervention Type DRUG

Sevoflurane 2.5% combined with ciprofol 0.05, 0.1, 0.15, 0.2, 0.3mg/kg, respectively.

ciprofol group

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

Group Type EXPERIMENTAL

Ciprofol 0 + different end-expiratory concentration of sevoflurane

Intervention Type DRUG

Ciprofol 0 combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5%, respectively.

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

Intervention Type DRUG

Ciprofol 0.05 mg/kg combined with sevoflurane 0.7, 1.5, 2.0, 2.5, 3.5 %, respectively.

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

Intervention Type DRUG

Ciprofol 0.1mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively.

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

Intervention Type DRUG

Ciprofol 0.2 mg/kg combined with sevoflurane 0.5, 1.5, 2.0, 2.5, 3.0 %, respectively.

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

Intervention Type DRUG

Ciprofol 0.3 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively.

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

Intervention Type DRUG

Ciprofol 0.4 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively.

Interventions

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Sevoflurane 0 + different doses of ciprofol

Sevoflurane 0% combined with ciprofol 0.1, 0.2, 0.3, 0.4, 0.6mg/kg, respectively.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

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

Ciprofol 0.3 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively.

Intervention Type DRUG

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

Ciprofol 0.4 mg/kg combined with sevoflurane 0.5, 1.0, 1.5, 2.0, 2.5 %, respectively.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No