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Completed

NCT Number: NCT05789992

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

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.

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Key information

Conditions

General Anaesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);
  • 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.

Treatment and study plan

Propofol

Drug

Propofol (Random:3-5ug/ml)

Other names: Propofol for tetanic electrical stimulation and intubation

Low remifentanil

Drug

Remifentanil (Random:0-3ug/ml)

Other names: Remifentanil for tetanic electrical stimulation

Heigh Remifentanil

Drug

Remifentanil (Random:3-5ug/ml)

Other names: Remifentanil for intubation

Intubation

Procedure

Endotracheal intubation before surgery

tetanic electrical stimulation

Procedure

tetanic electrical stimulation before surgery

Primary outcomes

  1. Prediction probability of eMAC

    Time frame: 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 outcomes

  1. Prediction probability of BIS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhang Haopeng

Other

Registry information

Official study title

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

Acronym: eMAC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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