A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

Phase 4

Not yet recruiting

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

• Registration Number: NCT06773351
• Lead Sponsor: Feng Gao

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane group	Sevoflurane 0 + different doses of ciprofol	Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
sevoflurane group	Sevoflurane 2.0% + different doses of ciprofol	Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
sevoflurane group	Sevoflurane 0.7% + different doses of ciprofol	Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
sevoflurane group	Sevoflurane 1.5% + differnet doses of ciprofol	Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
sevoflurane group	Sevoflurane 2.5% + different doses of ciprofol	Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
ciprofol group	Ciprofol 0 + different end-expiratory concentration of sevoflurane	The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
sevoflurane group	Sevoflurane 1.0% + different doses of ciprofol 0.05	Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
ciprofol group	Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane	The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
ciprofol group	Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevoflurane	The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
ciprofol group	Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevoflurane	The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
ciprofol group	Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane	The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
ciprofol group	Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane	The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg

Primary Outcome Measures

Name	Time	Method
Bispectral Index (BIS) value	Induction period of anesthesia	The BIS usually ranges from 0 to 100, with 0-20 indicating a state of deep anesthesia or coma; 20-40 indicates moderate anesthesia; 40-60 indicates mild anesthesia; 60-80 indicates sedation; 80-100 indicates wakefulness.
The score of Observer's Assessment of Alertness/Sedation Scale	Induction period of anesthesia	The Observer's Assessment of Alertness/Sedation (OAAS) scale ranges from 1 to 5 points.; 5 (awake) : The patient responds quickly to the name call with normal intonation, normal verbal answers, normal facial expressions, and bright eyes without drooping.; 4 (mild sedation) : The patient is slow to respond to the name call in normal intonation, the verbal answer is slightly slow or vague, the facial expression is slightly relaxed, the eyes are glassy and the upper eyelid is slightly droopy.; 3 (moderate sedation) : The patient responds only to the name call out loud, verbal responses are significantly slower or slower, facial expressions are significantly relaxed, and eyes are fixed with a visibly droopy upper eyelid.; 2 (deep sedation) : The patient responds only to nudging or shaking, and the verbal response is indistinct.; 1 (deep sleep, unconscious) : The patient does not respond to nudging or shaking.; An OAA/S score of 2-5 is considered a response.
Numbers of of participants with laryngoscopy and tracheal intubation positive response	Induction period of anesthesia	Laryngoscopic exposure of the glottis to obtain Cormack-Lehane level 1 or 2 visual field and maintain it for 5 seconds: verbal response, eye opening, painful expression, coughing, retraction, or other purposeful or unpurposeful movements are considered responsive.
Numbers of participants with tracheal intubation stress positive respose	Induction period of anesthesia	If the increase in heart rate (HR) or mean arterial pressure (MAP) compared to the baseline value was greater than or equal to 15% during this procedure, the stress response induced by tracheal intubation was considered to have failed to be effectively suppressed, and the effect was recorded as 1.
Blood plasma concentration	Induction period of anesthesia

Secondary Outcome Measures

Name	Time	Method
HR	Period of anesthesia	For adults, the normal heart rate range is usually between 60 and 100 beats per minute. During anesthesia, HR less than 20% of baseline is considered hypotensive
Adverse reactions	Perioperative period
MAP	Period of anesthesia	The normal range of MAP is usually 70-105 mmHg. MAP is one of the important indicators to measure the function of the human circulatory system, which represents the average arterial blood pressure in a cardiac cycle. During anesthesia, MSP less than 20% of baseline is considered hypotensive.