Evaluation of Equivalent Minimum Alveolar Concentration (eMAC) During Propofol/Remifentanil Anesthesia
eMAC
Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration (eMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2023
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedStudy Start
First participant enrolled
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2023
CompletedJune 15, 2023
June 1, 2023
26 days
March 2, 2023
June 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Prediction probability of BIS
1 year
Study Arms (4)
Group 1 BIS under tetanic electrical stimulation
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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
ACTIVE COMPARATORDuring 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.
Interventions
Propofol (Random:3-5ug/ml)
Remifentanil (Random:0-3ug/ml)
Remifentanil (Random:3-5ug/ml)
Endotracheal intubation before surgery
tetanic electrical stimulation before surgery
Eligibility Criteria
You may qualify if:
- Patients undergoing elective surgery under general anesthesia;
- Patients with ASA rating I\~III;
- The age of the patient is more than 18 years old;
- The informed consent has been signed;
You may not qualify if:
- Patients who are participating in other trials;
- Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;
- Patients with a history of stroke;
- Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);
- Pregnant women;
- Patients with BMI\>30;
- Patients and family members who are unwilling to participate after understanding the research content;
- According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhang Haopenglead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, China
Related Publications (3)
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.
PMID: 20216387BACKGROUNDGruenewald 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.
PMID: 23471754BACKGROUNDSchumacher 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.
PMID: 19741484BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haopeng Zhang, Dr
Xijing Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 2, 2023
First Posted
March 29, 2023
Study Start
April 3, 2023
Primary Completion
April 29, 2023
Study Completion
April 29, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06