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Evaluation of Multi-drug Integrated Minimum Alveolar Concentration (iMAC) During Propofol/Remifentanil Anesthesia (iMAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05789992
Recruitment Status : Not yet recruiting
First Posted : March 29, 2023
Last Update Posted : March 29, 2023
Sponsor:
Information provided by (Responsible Party):
Zhang Haopeng, Xijing Hospital

Study Description
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Brief Summary:
The aim of this study is to verify the accuracy of iMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.

Condition or disease Intervention/treatment Phase
General Anaesthesia Drug: Propofol Drug: Low Remifentanil Drug: Heigh Remifentanil Procedure: Intubation Procedure: tetanic electrical stimulation Not Applicable

Detailed Description:

iMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-2 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, iMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, iMAC during maintenance period of perioperative.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Nociceptive Stimulation and Anesthesia State by Multi-drug Integrated Minimum Alveolar Concentration(iMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations
Estimated Study Start Date : March 31, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1 BIS under tetanic electrical stimulation
During tetanic electrical stimulation , and with propofol(random:0-2ug/ml) and remifentanil(random:0-2ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
 Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Name: Propofol for tetanic electrical stimulation and intubation

Drug: Low Remifentanil
Remifentanil (Random:0-2ug/ml)
Other Name: Remifentanil for tetanic electrical stimulation

Procedure: tetanic electrical stimulation
tetanic electrical stimulation before surgery
Active Comparator: Group 2 iMAC under tetanic electrical stimulation
During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-2ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's iMAC.
 Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Name: Propofol for tetanic electrical stimulation and intubation

Drug: Low Remifentanil
Remifentanil (Random:0-2ug/ml)
Other Name: Remifentanil for tetanic electrical stimulation

Procedure: tetanic electrical stimulation
tetanic electrical stimulation before surgery
Active Comparator: Group 3 BIS under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
 Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Name: Propofol for tetanic electrical stimulation and intubation

Drug: Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)
Other Name: Remifentanil for intubation

Procedure: Intubation
Endotracheal intubation before surgery
Active Comparator: Group 4 iMAC under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's iMAC.
 Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Name: Propofol for tetanic electrical stimulation and intubation

Drug: Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)
Other Name: Remifentanil for intubation

Procedure: Intubation
Endotracheal intubation before surgery


Outcome Measures
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Primary Outcome Measures :
  1. Prediction probability of iMAC [ Time Frame: 1 year ]
    Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween iMAC and the lable of response was calculated.


Secondary Outcome Measures :
  1. Prediction probability of BIS [ Time Frame: 1 year ]
    Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween BIS and the lable of response was calculated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing elective surgery under general anesthesia;
  2. Patients with ASA rating I~III;
  3. The age of the patient is more than 18 years old;
  4. The informed consent has been signed;

Exclusion Criteria:

  1. Patients who are participating in other trials;
  2. Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;
  3. Patients with a history of stroke;
  4. Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);
  5. Pregnant women;
  6. Patients with BMI>30;
  7. Patients and family members who are unwilling to participate after understanding the research content;
  8. According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05789992


Contacts
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Contact: Haopeng Zhang, PhD 029-84775343 843940833@qq.com

Locations
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China, Shaanxi
Xijing Hospital
Xian, Shaanxi, China
Sponsors and Collaborators
Zhang Haopeng
Investigators
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Principal Investigator: Haopeng Zhang, Dr Xijing Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Zhang Haopeng, Associate professor, Xijing Hospital
ClinicalTrials.gov Identifier: NCT05789992    
Other Study ID Numbers: 202302
First Posted: March 29, 2023    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Remifentanil
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents