NCT05789992

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Zhang Haopeng · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Anaesthesia

Interventions

Type	Name	Description
DRUG	Propofol	Propofol (Random:3-5ug/ml)
DRUG	Low Remifentanil	Remifentanil (Random:0-3ug/ml)
DRUG	Heigh Remifentanil	Remifentanil (Random:3-5ug/ml)
PROCEDURE	Intubation	Endotracheal intubation before surgery
PROCEDURE	tetanic electrical stimulation	tetanic electrical stimulation before surgery

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-04-29
• Completion: 2023-04-29
• First posted: 2023-03-29
• Last updated: 2023-06-15

Locations

1 site across 1 country: China