Electromyographic Calibration Guided by Depth of Anesthesia (CELESTE)

Does Calibration of Electromyography Guided by State Entropy Improve Measurement Precision

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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Blockade

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Germany
  • Baden-Wurttemberg
    • Ulm, Baden-Wurttemberg, Germany, 89073
      • University Hospital Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The CELESTE study will be performed in adult patients scheduled for elective non-cardiac surgery requiring general anesthesia and moderate neuromuscular blockade.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precision of Train-of-four measurements	repeatability coefficient	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall of calibration		postoperative day 1
Discomfort with calibration		postoperative day 1
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.	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

Collaborators and Investigators

• Sponsor: University Hospital Ulm
• Collaborators: Klinikum rechts der Isar Technische Universität München
• Investigators: Principal Investigator: Manfred Blobner, MD PhD, Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: electromyography; residual paralysis; calibration
• Other Study ID Numbers: CELESTE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No