NCT07739862

Brief Summary

This prospective observational study aims to evaluate the agreement between acceleromyography and electromyography for measuring train-of-four (TOF) ratio at the end of surgery before reversal of neuromuscular blockade. Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade will undergo simultaneous TOF measurements using both monitoring methods. The study will assess the agreement between the two techniques, estimate measurement bias and limits of agreement, and determine the frequency of clinically relevant disagreement that could affect assessment of neuromuscular recovery and safe extubation.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 24, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

AcceleromyographyElectromyographyTrain-of-FourTOF RatioNeuromuscular MonitoringResidual Neuromuscular BlockadeGeneral AnesthesiaLaparoscopic CholecystectomyBland-Altman AnalysisDiagnostic Agreement

Outcome Measures

Primary Outcomes (1)

  • Agreement Between Acceleromyography and Electromyography Train-of-Four Ratios

    Agreement between the train-of-four (TOF) ratios measured simultaneously by acceleromyography and electromyography at the end of surgery. Agreement between the two measurement methods will be evaluated using Bland-Altman analysis.

    At the end of surgery, before administration of neuromuscular blockade reversal agents

Secondary Outcomes (4)

  • Mean Bias Between Acceleromyography and Electromyography TOF Ratios

    At the end of surgery, before administration of neuromuscular blockade reversal agents

  • Ninety-Five Percent Limits of Agreement Between TOF Monitoring Methods

    At the end of surgery, before administration of neuromuscular blockade reversal agents

  • Proportional Bias Between Acceleromyography and Electromyography TOF Ratios

    At the end of surgery, before administration of neuromuscular blockade reversal agents

  • Proportion of Participants With False Neuromuscular Recovery Indicated by Acceleromyography

    At the end of surgery, before administration of neuromuscular blockade reversal agents

Study Arms (1)

Adults Undergoing Elective Laparoscopic Cholecystectomy

Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade. Simultaneous train-of-four (TOF) ratio measurements will be obtained at the end of surgery using acceleromyography and electromyography before administration of neuromuscular blockade reversal agents.

Diagnostic Test: Simultaneous Acceleromyography and Electromyography Monitoring

Interventions

Simultaneous quantitative neuromuscular monitoring using acceleromyography and electromyography to measure the train-of-four (TOF) ratio at the end of surgery before administration of neuromuscular blockade reversal agents.

Adults Undergoing Elective Laparoscopic Cholecystectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia with non-depolarizing neuromuscular blockade at Clínica Dávila.

You may qualify if:

  • Adults aged 18 years or older.
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
  • Administration of non-depolarizing neuromuscular blocking agents.
  • Written informed consent provided.

You may not qualify if:

  • Pre-existing neuromuscular disease.
  • Upper extremity abnormalities preventing neuromuscular monitoring.
  • Contraindications to neuromuscular monitoring.
  • Refusal or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Dávila

Santiago, Santiago Metropolitan, 8431657, Chile

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dagoberto Ojeda, MD

    Clínica Dávila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 31, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. Only aggregate study results will be reported in scientific publications and presentations. Participant confidentiality will be protected in accordance with institutional policies and applicable ethical and regulatory requirements.

Locations