Neuromuscular BlockadeCELESTENCT04911088
Electromyographic Calibration Guided by Depth of Anesthesia
An observational study of Neuromuscular Blockade, run by University Hospital Ulm at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2022to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The CELESTE study will be performed in adult patients scheduled for elective non-cardiac surgery requiring general anesthesia and moderate neuromuscular blockade.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuromuscular Blockade
- Keywords
- electromyography, calibration, residual paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Precision of Train-of-four measurements
repeatability coefficient
Measured: intraoperative
Secondary outcomes (5)
Tolerance interval of Train-of-four ratios
Measured: 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.
Measured: 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.
Measured: intraoperative
Recall of calibration
Measured: postoperative day 1
Discomfort with calibration
Measured: postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start16 Jan 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Principal investigator, Manfred Blobner, University Hospital Ulm
- Investigators
- Manfred Blobner, MD PhD, Principal investigator, Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911088
- Sponsor's protocol ID
- CELESTE-01
- Acronym
- CELESTE
- Status last verified
- Jan 2024
- First submitted
- 27 May 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 40437152
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Calibration of Electromyography Guided by State Entropy Improve Measurement Precision
- ClinicalTrials.gov ID
- NCT04911088
- Acronym / sponsor ID
- CELESTE / CELESTE-01
- Conditions
- Neuromuscular Blockade
- Keywords
- electromyography, calibration, residual paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital UlmUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CELESTE study will be performed in adult patients scheduled for elective non-cardiac surgery requiring general anesthesia and moderate neuromuscular blockade.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Precision of Train-of-four measurements
Time frame: intraoperative
repeatability coefficient
5 secondary outcomes
Tolerance interval of Train-of-four ratios
Time frame: intraoperative
Agreement of EMG calibration group Train-of-four and standard Train-of-four
Time frame: intraoperative
Time difference between calibration group Train-of-four and standard Train-of-four to complete recovery
Time frame: intraoperative
Recall of calibration
Time frame: postoperative day 1
Discomfort with calibration
Time frame: postoperative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 40437152Scheffenbichler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Blobner, MD PhD principal investigator
Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by University Hospital Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision of Train-of-four measurements (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04911088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.