Electromyographic Calibration Guided by Depth of Anesthesia

Neuromuscular Blockade Clinical Trial

— CELESTE  

Official title:

Does Calibration of Electromyography Guided by State Entropy Improve Measurement Precision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04911088
• Other study ID #: CELESTE-01
• Status: Completed
• Start date: January 16, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2024
• Source: University Hospital Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Locations

Country	Name	City	State
Germany	University Hospital Ulm	Ulm	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ulm	Technical University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision of TOF measurements	repeatability coefficient	intraoperative
Secondary	Tolerance interval of TOF ratios		intraoperative
Secondary	Agreement of EMG calibration group TOF and standard TOF	Agreement of both calibration group EMG and standard EMG regarding the decision whether complete neuromuscular recovery is given based on a TOF ratio of >0.9 or >0.95, respectively.	intraoperative
Secondary	Time difference between calibration group TOF and standard TOF to complete recovery	Time difference between calibration group EMG and the standard EMG reaching a TOF ratio >0.9 or >0.95, respectively.	intraoperative
Secondary	Recall of calibration		postoperative day 1
Secondary	Discomfort with calibration		postoperative day 1