Neuromuscular Blockade
Conditions
Keywords
electromyography, calibration, residual paralysis
Brief summary
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
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.
Interventions
None listed
Sponsors
University Hospital Ulm
Klinikum rechts der Isar Technische Universität München
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precision of Train-of-four measurements | intraoperative | repeatability coefficient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance interval of Train-of-four ratios | intraoperative | — |
| Agreement of EMG calibration group Train-of-four and standard Train-of-four | 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 difference between calibration group Train-of-four and standard Train-of-four to complete recovery | intraoperative | Time difference between calibration group EMG and the standard EMG reaching a Train-of-four ratio \>0.9 or \>0.95, respectively. |
| Recall of calibration | postoperative day 1 | — |
| Discomfort with calibration | postoperative day 1 | — |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORManfred Blobner, MD PhD
Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.
Outcome results
None listed