A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Induction of General Anesthesia
• Intervention / Treatment: Drug: Sevoflurane 0 + different doses of ciprofol; Drug: Sevoflurane 0.7% + different doses of ciprofol; Drug: Sevoflurane 1.0% + different doses of ciprofol 0.05; Drug: Sevoflurane 1.5% + differnet doses of ciprofol; Drug: Sevoflurane 2.0% + different doses of ciprofol; Drug: Sevoflurane 2.5% + different doses of ciprofol; Drug: Ciprofol 0 + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane; Drug: Ciprofol 0.2 mg/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

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Feng Gao, PhD; Phone Number: +86 13971587381; Email: fgao@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sevoflurane group; Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%	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.
Experimental: ciprofol group; The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg	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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bispectral Index (BIS) value	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.	Induction period of anesthesia
The score of Observer's Assessment of Alertness/Sedation Scale	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.	Induction period of anesthesia
Numbers of of participants with laryngoscopy and tracheal intubation positive response	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.	Induction period of anesthesia
Numbers of participants with tracheal intubation stress positive respose	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.	Induction period of anesthesia
Blood plasma concentration		Induction period of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HR	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	Period of anesthesia
MAP	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.	Period of anesthesia
Adverse reactions		Perioperative period

Collaborators and Investigators

• Sponsor: Feng Gao
• Collaborators: Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: ciprofol; response surface analysis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: TJ-IRB202412125; S219 (Other Grant/Funding Number: Beijing Kangmeng Charity Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes