Evaluation of Equivalent Minimum Alveolar Concentration (eMAC) During Propofol/Remifentanil Anesthesia (eMAC)

June 13, 2023 updated by: Zhang Haopeng

Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration (eMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations

The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

eMAC 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 0-3 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, eMAC 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, eMAC during maintenance period of perioperative.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xian, Shaanxi, China
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Propofol for tetanic electrical stimulation and intubation
Drug: Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)
Other Names:
  • Remifentanil for intubation
Procedure: Intubation
Endotracheal intubation before surgery
Active Comparator: Group 1 BIS under tetanic electrical stimulation
During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Names:
  • Propofol for tetanic electrical stimulation and intubation
Procedure: tetanic electrical stimulation
tetanic electrical stimulation before surgery
Drug: Low Remifentanil
Remifentanil (Random:0-3ug/ml)
Other Names:
  • Remifentanil for tetanic electrical stimulation
Active Comparator: Group 2 eMAC under tetanic electrical stimulation
During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Names:
  • Propofol for tetanic electrical stimulation and intubation
Procedure: tetanic electrical stimulation
tetanic electrical stimulation before surgery
Drug: Low Remifentanil
Remifentanil (Random:0-3ug/ml)
Other Names:
  • Remifentanil for tetanic electrical stimulation
Active Comparator: Group 4 eMAC 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 eMAC.
Drug: Propofol
Propofol (Random:3-5ug/ml)
Other Names:
  • Propofol for tetanic electrical stimulation and intubation
Drug: Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)
Other Names:
  • Remifentanil for intubation
Procedure: Intubation
Endotracheal intubation before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction probability of eMAC
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 eMAC and the lable of response was calculated.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang Haopeng

Investigators

  • Principal Investigator: Haopeng Zhang, Dr, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2023

Primary Completion (Actual)

April 29, 2023

Study Completion (Actual)

April 29, 2023

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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