Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06220136

Comparison of the Train-of-Four Ratio and Modified Train-of-Four Ratio During Reversal of Deep Neuromuscular Blockade With Sugammadex

Led by Ankara University · Updated on 2026-02-12

199

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of two different methods to monitor recovery from deep neuromuscular blockade during surgery. This study focuses on comparing the traditional train-of-four ratio (cTOFR) and a modified train-of-four ratio (mTOFR) to see which better indicates safe extubation when reversing blockade with the drug sugammadex. The study is observational and addresses concerns about postoperative complications caused by residual neuromuscular block after anesthesia. Participants will undergo anesthesia involving rocuronium to induce muscle relaxation, followed by monitoring with the TOFscan device, which measures neuromuscular function. Sugammadex will be administered to reverse the blockade, and researchers will record classical and modified TOF ratios until full recovery is confirmed. The anesthesia process includes specific medication dosing, monitoring with multiple devices, and maintaining muscle relaxation at targeted levels during surgery. During the study, participants will be closely monitored with ECG, blood pressure, oxygen levels, brain activity, and acceleromyography. Neuromuscular function will be assessed repeatedly until reversal is complete. Data on drug use, TOF ratios, and recovery times will be collected. The primary outcome is the time measured up to 15 minutes, with a secondary outcome at 30 minutes. Participants will be observed until both TOF ratios reach 100%, ensuring complete neuromuscular recovery.

CONDITIONS

Brief Title

Comparison of the Performances of the cTOFR and the mTOFR During Reversal of Deep Neuromuscular Blockade With Sugammadex

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years (not including 65)
  • Body mass index (BMI) between 18.5 and 24.9
Not Eligible

You will not qualify if you...

  • Liver or kidney disease
  • Not consenting to participate
  • Emergency surgeries
  • Muscle disease
  • Allergy to rocuronium or sugammadex
  • Predicted difficult mask ventilation or intubation
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to the duration of surgery and immediate post-surgery period

Participants are monitored during surgery with TOFscan to observe neuromuscular function and record classical and modified Train-of-Four ratios while receiving rocuronium and sugammadex.

1 continuous monitoring session during surgery

Post-operative Follow-up

Duration - Until full neuromuscular recovery (minutes after surgery)

Participants are observed in the operating room until neuromuscular function recovers fully, with TOFscan monitoring continuing until classical and modified TOF ratios reach 100%.

Continuous observation post-surgery

Trial Site Locations

Total: 1 location

1

Ankara University

Ankara, Altındağ, Turkey (Türkiye), 06230

Actively Recruiting

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Research Team

H

Hatice Güneş Yeşilova, 1

M

Menekşe Özçelik, 2

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block.

Glenn S Murphy, Sorin J Brull

https://pubmed.ncbi.nlm.nih.gov/20442260

2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade: A Report by the American Society of Anesthesiologists Task Force on Neuromuscular Blockade.

Stephan R Thilen, Wade A Weigel, Michael M Todd...

https://pubmed.ncbi.nlm.nih.gov/36520073

Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care.

Thomas Fuchs-Buder, Carolina S Romero, Heidrun Lewald...

https://pubmed.ncbi.nlm.nih.gov/36377554