Skip to main content
OpenTrials
Completed

NCT Number: NCT04911088

Electromyographic Calibration Guided by Depth of Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ulm

Ulm, Baden-Wurttemberg, 89073, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Precision of Train-of-four measurements

    Time frame: intraoperative

    repeatability coefficient

Secondary outcomes

  1. Tolerance interval of Train-of-four ratios

    Time frame: intraoperative

  2. Agreement of EMG calibration group Train-of-four and standard Train-of-four

    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.

  3. Time difference between calibration group Train-of-four and standard Train-of-four to complete recovery

    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.

  4. Recall of calibration

    Time frame: postoperative day 1

  5. Discomfort with calibration

    Time frame: postoperative day 1

Sponsors and collaborators

Lead sponsor

University Hospital Ulm

Other

Collaborators

  • Klinikum rechts der Isar Technische Universität München

Registry information

Official study title

Does Calibration of Electromyography Guided by State Entropy Improve Measurement Precision

Acronym: CELESTE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2021
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.