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NCT Number: NCT06773351

A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

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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Key information

Conditions

Induction of General Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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 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 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 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.

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 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 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 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 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 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Blood plasma concentration

    Time frame: Induction period of anesthesia

Secondary outcomes

  1. HR

    Time frame: 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

  2. MAP

    Time frame: 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.

  3. Adverse reactions

    Time frame: Perioperative period

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Gao, PhD

CONTACT

[email protected]

+86 13971587381

Sponsors and collaborators

Lead sponsor

Feng Gao

Other

Collaborators

  • Sichuan Provincial People's Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.