Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Klinikum rechts der Isar Technische Universität München | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analgesic calibration | Participants will receive calibration of electromyography at state entropy of 90. | ||
| Sedated calibration | Calibration will be started at state entropy of 70. | ||
| No calibration | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Precision of Train-of-four measurements | repeatability coefficient | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance interval of Train-of-four ratios | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The CELESTE study will be performed in adult patients scheduled for elective non-cardiac surgery requiring general anesthesia and moderate neuromuscular blockade.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manfred Blobner, MD PhD | Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ulm | Ulm | Baden-Wurttemberg | 89073 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40437152 | Derived | Scheffenbichler FT, Ulm B, Borgstedt L, Scholze A, Kretsch N, Zia N, Friedrich V, Marb M, Schaller SJ, Jungwirth B, Blobner M. Precision of electromyography according to the calibration approach of neuromuscular monitoring: a randomised prospective agreement study. J Clin Monit Comput. 2025 Oct;39(5):1047-1056. doi: 10.1007/s10877-025-01304-z. Epub 2025 May 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | intraoperative |
| Recall of calibration | postoperative day 1 |
| Discomfort with calibration | postoperative day 1 |