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

Not Applicable

Completed

• Conditions: General Anaesthesia
• Interventions: Drug: Propofol; Drug: Low Remifentanil; Drug: Heigh Remifentanil; Procedure: tetanic electrical stimulation; Procedure: Intubation

• Registration Number: NCT05789992
• Lead Sponsor: Zhang Haopeng

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-29
• Study Start: 2023-04-03
• Primary Completion: 2023-04-29
• Study Completion: 2023-04-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 BIS under tetanic electrical stimulation	Low Remifentanil	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.
Group 1 BIS under tetanic electrical stimulation	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.
Group 3 BIS under intubation	Heigh Remifentanil	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.
Group 2 eMAC under tetanic electrical stimulation	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.
Group 4 eMAC under intubation	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.
Group 2 eMAC under tetanic electrical stimulation	Low Remifentanil	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.
Group 3 BIS under intubation	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.
Group 4 eMAC under intubation	Heigh Remifentanil	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.
Group 1 BIS under tetanic electrical stimulation	Propofol	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.
Group 2 eMAC under tetanic electrical stimulation	Propofol	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.
Group 3 BIS under intubation	Propofol	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.
Group 4 eMAC under intubation	Propofol	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.

Primary Outcome Measures

Name	Time	Method
Prediction probability of eMAC	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.

Secondary Outcome Measures

Name	Time	Method
Prediction probability of BIS	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.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xian, Shaanxi, China