Evaluation of Multi-drug Integrated Minimum Alveolar Concentration (iMAC) During Propofol/Remifentanil Anesthesia
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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 Names:
Drug: Low Remifentanil
Remifentanil (Random:0-2ug/ml)
Other Names:
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 Names:
Drug: Low Remifentanil
Remifentanil (Random:0-2ug/ml)
Other Names:
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 Names:
Drug: Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)
Other Names:
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 Names:
Drug: Heigh Remifentanil
Remifentanil (Random:3-5ug/ml)
Other Names:
Procedure: Intubation
Endotracheal intubation before surgery
|
Outcome Measures
Primary Outcome Measures
- Prediction probability of iMAC [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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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;
Exclusion Criteria:
-
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);
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Pregnant women;
-
Patients with BMI>30;
-
Patients and family members who are unwilling to participate after understanding the research content;
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According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hospital | Xian | Shaanxi | China |
Sponsors and Collaborators
- Zhang Haopeng
Investigators
- Principal Investigator: Haopeng Zhang, Dr, Xijing Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
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