University Hospital Ulm
Ulm, Baden-Wurttemberg, 89073, Germany
NCT Number: NCT04911088
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.
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Notify Me18 year and older
All sexes
Observational
Ulm, Baden-Wurttemberg, 89073, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: intraoperative
repeatability coefficient
Time frame: intraoperative
Time frame: intraoperative
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 EMG and the standard EMG reaching a Train-of-four ratio >0.9 or >0.95, respectively.
Time frame: postoperative day 1
Time frame: postoperative day 1
University Hospital Ulm
Other
Does Calibration of Electromyography Guided by State Entropy Improve Measurement Precision
Acronym: CELESTE
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