A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

NCT06773351 | Not Yet Recruiting Phase 4

• 2 other identifiers: TJ-IRB202412125S219
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Induction of General Anesthesia

Keywords

ciprofol; response surface analysis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• HR

  Period of anesthesia

• MAP

  Period of anesthesia

• Adverse reactions

  Perioperative period

Study Arms (2)

sevoflurane group

EXPERIMENTAL

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

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

ciprofol group

EXPERIMENTAL

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; 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

Interventions

Sevoflurane 0 + different doses of ciprofol DRUG

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

sevoflurane group

Sevoflurane 0.7% + different doses of ciprofol DRUG

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

sevoflurane group

Sevoflurane 1.0% + different doses of ciprofol 0.05 DRUG

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

sevoflurane group

Sevoflurane 1.5% + differnet doses of ciprofol DRUG

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

sevoflurane group

Sevoflurane 2.0% + different doses of ciprofol DRUG

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

sevoflurane group

Sevoflurane 2.5% + different doses of ciprofol DRUG

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

sevoflurane group

Ciprofol 0 + different end-expiratory concentration of sevoflurane DRUG

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

ciprofol group

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

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

ciprofol group

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

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

ciprofol group

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

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

ciprofol group

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

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

ciprofol group

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

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

ciprofol group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Feng Gao: lead
• Sichuan Provincial People's Hospital: collaborator

MeSH Terms

Interventions

Sevoflurane; (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

Feng Gao, PhD

CONTACT

+86 13971587381; fgao@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 14, 2025
• Study Start: February 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01