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

General Anaesthesia Clinical Trial

— eMAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789992
• Other study ID #: 202302
• Status: Completed
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: April 29, 2023

Study information

• Verified date: June 2023
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 29, 2023
• Est. primary completion date: April 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Anaesthesia

Intervention

Drug:
• Propofol
Propofol (Random:3-5ug/ml)
• Low Remifentanil
Remifentanil (Random:0-3ug/ml)
• Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)

Procedure:
• Intubation
Endotracheal intubation before surgery
• tetanic electrical stimulation
tetanic electrical stimulation before surgery

Locations

Country	Name	City	State
China	Xijing Hospital	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Haopeng

Country where clinical trial is conducted

China, 

References & Publications (3)

Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6. — View Citation

Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368. — View Citation

Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction probability of eMAC	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	Prediction probability of BIS	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

External Links

•   For PubMed ID: 19741484
•   For PubMed ID: 20216387