Electromyographic Calibration Guided by Depth of Anesthesia

Study Overview
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Brief Summary
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The goal of the CELESTE study is to evaluate whether calibration of EMG is needed for reliable interpretation of neuromuscular function and if so, to identify the minimal necessary depth of anesthesia.

Detailed Description
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Neuromuscular monitoring is used to document neuromuscular function intra-operatively. Failure to restore neuromuscular function prior to extubation results in residual neuromuscular blockade which is associated with increased postoperative morbidity and mortality. It is essential to document baseline neuromuscular function before administration of the neuromuscular blocking agent. However, during anesthesia induction, neuromuscular monitoring is rarely calibrated due to its time-consuming nature coinciding with the patients' loss of consciousness. The CELESTE trial is a randomized, prospective, observational proof-of-concept study. We plan to enroll sixty adult participants scheduled for elective non-cardiac surgery requiring general anesthesia with moderate neuromuscular blockade. Participants will be randomized into three electromyography (EMG) calibration groups: based on state entropy (depth of anesthesia), group 1 will receive analgesic calibration, group 2 sedated calibration, and group 3 no calibration. Participants will be randomly allocated to receive calibration at a certain depth of anesthesia. All participants will receive a standard EMG performed on the contralateral arm. Standard EMG will be calibrated at state entropy of 50.

Official Title
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Does Calibration of Electromyography Guided by State Entropy Improve Measurement Precision

Conditions
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Neuromuscular Blockade

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed informed written consent BMI 17.5-30 kg/m^2 ASA <= 3 supine positioning during surgery with intraoperative access to both arms absence of allergy to muscle relaxants and reversal agents absence of neuromuscular disease Exclusion Criteria: ambulatory patients for whom discharge is planned within 12 hours of anaesthesia patients undergoing minor surgical procedures scheduled outside the operating room patients who are endotracheally intubated prior to surgery pregnancy indication for rapid sequence induction patients undergoing arm surgery patients with preceding injuries impairing muscle or nerve function of the arm (e.g., finger amputation)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Analgesic calibration<br>Participants will receive calibration of electromyography at state entropy of 90. | |
| Sedated calibration<br>Calibration will be started at state entropy of 70. | |
| No calibration<br>Participants will not receive calibration of electromyography. Measurements will start simultaneously to the standard electromyography with a default current of 60mA at state entropy of 50. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance interval of TOF ratios |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of TOF measurements | repeatability coefficient | intraoperative | 
| Agreement of EMG calibration group TOF and standard TOF | Agreement of both calibration group EMG and standard EMG regarding the decision whether complete neuromuscular recovery is given based on a TOF ratio of >0.9 or >0.95, respectively. | intraoperative | 
| Time difference between calibration group TOF and standard TOF to complete recovery | Time difference between calibration group EMG and the standard EMG reaching a TOF ratio >0.9 or >0.95, respectively. | intraoperative | 
| Recall of calibration |  | postoperative day 1 | 
| Discomfort with calibration |  | postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electromyography, calibration, residual paralysis