A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane During Anesthesia Induction
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Bispectral Index (BIS) value
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
sevoflurane group
Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
Intervention: Sevoflurane 0 + different doses of ciprofol (Drug)
sevoflurane group
Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
Intervention: Sevoflurane 0.7% + different doses of ciprofol (Drug)
sevoflurane group
Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
Intervention: Sevoflurane 1.0% + different doses of ciprofol 0.05 (Drug)
sevoflurane group
Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
Intervention: Sevoflurane 1.5% + differnet doses of ciprofol (Drug)
sevoflurane group
Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
Intervention: Sevoflurane 2.0% + different doses of ciprofol (Drug)
sevoflurane group
Sevoflurane doses were 0,0.7, 1.0, 1.5, 2.0, 2.5%
Intervention: Sevoflurane 2.5% + different doses of ciprofol (Drug)
ciprofol group
The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
Intervention: Ciprofol 0 + different end-expiratory concentration of sevoflurane (Drug)
ciprofol group
The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
Intervention: Ciprofol 0.05mg/kg + different end-expiratory concentration of sevoflurane (Drug)
ciprofol group
The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
Intervention: Ciprofol 0.1mg/kg + different end-expiratory concentration of sevoflurane (Drug)
ciprofol group
The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
Intervention: Ciprofol 0.2 mg/kg + different end-expiratory concentration of sevoflurane (Drug)
ciprofol group
The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
Intervention: Ciprofol 0.3 mg/kg + different end-expiratory concentration of sevoflurane (Drug)
ciprofol group
The doses of ciprofol were 0, 0.05, 0.1, 0.2, 0.3, 0.4mg/kg
Intervention: Ciprofol 0.4 mg/kg + different end-expiratory concentration of sevoflurane (Drug)
Outcomes
Primary Outcomes
Bispectral Index (BIS) value
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Induction period of anesthesia
Secondary Outcomes
- HR(Period of anesthesia)
- Adverse reactions(Perioperative period)
- MAP(Period of anesthesia)
Investigators
Feng Gao
Professor
Tongji Hospital