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A Response Surface Analysis for the Interaction Between Ciprofol and Sevoflurane

ConditionInduction of General Anesthesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorFeng Gao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: sevoflurane groupExperimental treatment 6 interventions
Group B: ciprofol groupExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Induction period of anesthesia
2

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.

Time frame
Induction period of anesthesia
3

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.

Time frame
Induction period of anesthesia
4

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.

Time frame
Induction period of anesthesia

Secondary outcomes

1

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

Time frame
Period of anesthesia
2

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.

Time frame
Period of anesthesia
3

Adverse reactions

Time frame
Perioperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Feng Gao

Lead sponsor

Tongji Hospital

Sponsor institution

Sichuan Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov

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