NCT06220136

Brief Summary

It is known that deep neuromuscular block improves surgical conditions, especially during laparoscopic abdominal surgery. Based on this, in the Perioperative Neuromuscular Blockade Management guide published by the ESAIC association in 2022, it is recommended to deepen the level of neuromuscular blockade in cases where surgical conditions need to be improved. Sugammadex should be used to quickly and reliably reverse deep neuromuscular blockade. TOFScan, a 3-dimensional acceleromyograph for neuromuscular monitoring, has become widely used in recent years. With this monitor, it has been shown that in addition to the classical train-of-four ratio (cTOFR), the modified train-of-four ratio (mTOFR) can be used during the spontaneous recovery of nondepolarizing neuromuscular blockade. In a study conducted by Schmartz et al. in 2021, it was shown that mTOFR, which is the ratio of T4 to the reference stimulus, was compiled later than cTOFR. Therefore, it is suggested that the mTOFR value is a better determinant for safe extubation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2024Jun 2026

First Submitted

Initial submission to the registry

January 2, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 2, 2024

Last Update Submit

February 11, 2026

Conditions

Neuromuscular BlockadeAnesthesia, General

Keywords

neuromuscular blockadeneuromuscular junction monitoringTOFscanmodified TOF ratio

Outcome Measures

Primary Outcomes (1)

  • time

    Comparison of classical and modified TOF rates to reach 90% and above

    15 minutes

Secondary Outcomes (1)

  • time

    30 minutes

Study Arms (1)

single group

rocuronium drug administration TOFscan monitoring administration of sugammadex drug recording of classical TOF and modified TOF values

Device: TOFscan monitoring

Interventions

TOFscan monitoringDEVICE

observation and data recording

single group

Eligibility Criteria

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

Surgeries where neuromuscular blockers are used under general anesthesia

You may qualify if:

  • Age: 18 - 65 (not including 65)
  • BMI: 18.5-24.9

You may not qualify if:

  • Liver and kidney disease
  • Non-consenting
  • Emergency surgeries
  • Muscle disease
  • Allergy to rocuronium and sugammadex
  • Patients predicted to have difficult mask ventilation or difficult intubation
  • Pregnant and breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (4)

  • Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.

    PMID: 20442260BACKGROUND

  • Thilen SR, Weigel WA, Todd MM, Dutton RP, Lien CA, Grant SA, Szokol JW, Eriksson LI, Yaster M, Grant MD, Agarkar M, Marbella AM, Blanck JF, Domino KB. 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. Anesthesiology. 2023 Jan 1;138(1):13-41. doi: 10.1097/ALN.0000000000004379.

    PMID: 36520073BACKGROUND

  • Fuchs-Buder T, Romero CS, Lewald H, Lamperti M, Afshari A, Hristovska AM, Schmartz D, Hinkelbein J, Longrois D, Popp M, de Boer HD, Sorbello M, Jankovic R, Kranke P. Peri-operative management of neuromuscular blockade: A guideline from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol. 2023 Feb 1;40(2):82-94. doi: 10.1097/EJA.0000000000001769. Epub 2022 Nov 15.

    PMID: 36377554BACKGROUND

  • Schmartz D, Bernard P, Sghaier R, Fils JF, Fuchs-Buder T. A modified TOF-ratio to assess rocuronium-induced neuromuscular block: a comparison with the usual TOF-ratio. Anaesth Crit Care Pain Med. 2022 Aug;41(4):101088. doi: 10.1016/j.accpm.2022.101088. Epub 2022 Apr 27.

    PMID: 35489709BACKGROUND

Study Officials

  • Menekşe Özçelik, 1

    Ankara University

    STUDY DIRECTOR

  • Hatice Güneş Yeşilova, 2

    Ankara University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatice Güneş Yeşilova, 1

CONTACT

+905510495354htcguness@hotmail.com

Menekşe Özçelik, 2

CONTACT

+905333521400mozcelik@ankara.edu.tr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 23, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Locations

TU(1)