Electromyographic Calibration Guided by Depth of Anesthesia

University Hospital Ulm66 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuromuscular Blockade

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Ulm

Ulm, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Precision of Train-of-four measurements

repeatability coefficient

Time frame: intraoperative

Secondary Outcomes

Tolerance interval of Train-of-four ratios

Time frame: intraoperative

Agreement of EMG calibration group Train-of-four and standard Train-of-four

Agreement of both calibration group EMG and standard EMG regarding the decision whether complete neuromuscular recovery is given based on a Train-of-four ratio of \>0.9 or \>0.95, respectively.

Time frame: intraoperative

Time difference between calibration group Train-of-four and standard Train-of-four to complete recovery

Time difference between calibration group EMG and the standard EMG reaching a Train-of-four ratio \>0.9 or \>0.95, respectively.

Time frame: intraoperative

Recall of calibration

Time frame: postoperative day 1

Discomfort with calibration

Time frame: postoperative day 1

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.