Electromyographic Calibration Guided by Depth of Anesthesia

NCT04911088 | Completed

• 1 other identifier: CELESTE-01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Blockade

Keywords

electromyography; calibration; residual paralysis

Outcome Measures

Primary Outcomes (1)

• Precision of TOF measurements

  repeatability coefficient

  intraoperative

Secondary Outcomes (5)

• Tolerance interval of TOF ratios

  intraoperative

• Agreement of EMG calibration group TOF and standard TOF

  intraoperative

• Time difference between calibration group TOF and standard TOF to complete recovery

  intraoperative

• Recall of calibration

  postoperative day 1

• Discomfort with calibration

  postoperative day 1

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Ulm: lead
• Technical University of Munich: collaborator

Study Sites (1)

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Related Publications (1)

• 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.

  PMID: 40437152 DERIVED

Study Officials

• Manfred Blobner, MD PhD

  Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: January 16, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

DE (1)