NCT05294523

Brief Summary

To shorten induction time, some anesthesiologist gives a priming dose of muscle relaxant before starting Neuromuscular Transmission monitor (NMT). To properly evaluate neuromuscular function during the surgury, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, The investigators designed this study to find out.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

December 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

January 31, 2022

Last Update Submit

November 27, 2022

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

  • Supramaximal stimulation value

    whether the supramaximal stimulation changs after 2 minutes of priming dose of muscle relaxant use

    since general anesthesia induction to endotracheal tube intubation, about 10 minutes

Secondary Outcomes (4)

  • supramaximal stimulation value change by time

    since general anesthesia induction to endotracheal tube intubation, about 10 minutes

  • dose of rocuronium

    since general anesthesia induction to endotracheal tube intubation, about 10 minutes

  • Time to intubation

    since general anesthesia induction to endotracheal tube intubation, about 10 minutes

  • Intubation condition

    since general anesthesia induction to endotracheal tube intubation, about 10 minutes

Study Arms (3)

Rocuronium priming dose 0.06mg/kg

ACTIVE COMPARATOR

Add the priming dose of rocuronium 0.06mg/kg after the first supramaximal stimulation data measured

Procedure: Rocuronium priming dose

Rocuronium priming dose 0.12mg/kg

ACTIVE COMPARATOR

Add the priming dose of rocuronium 0.12mg/kg after the first supramaximal stimulation data measured

Procedure: Rocuronium priming dose

Rocuronium priming dose 0.18mg/kg

ACTIVE COMPARATOR

Add the priming dose of rocuronium 0.18mg/kg after the first supramaximal stimulation data measured

Procedure: Rocuronium priming dose

Interventions

Rocuronium priming dosePROCEDURE

Add the priming dose of rocuronium after the first supramaximal stimulation data measured

Rocuronium priming dose 0.06mg/kgRocuronium priming dose 0.12mg/kgRocuronium priming dose 0.18mg/kg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving general anesthesia and use rocuronium for induction

You may not qualify if:

  • Muscular disease
  • Peripheral neuropathy
  • Difficult airway or difficult mask ventilation
  • Allergy to study related medication
  • Pregnant woman
  • \< 20-year-old or \> 65-year-old
  • BMI \<18.5 or BMI\>24.9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 220, Taiwan

RECRUITING

Related Publications (4)

  • Kopman AF, Lawson D. Milliamperage requirements for supramaximal stimulation of the ulnar nerve with surface electrodes. Anesthesiology. 1984 Jul;61(1):83-5. No abstract available.

    PMID: 6742488BACKGROUND

  • Naguib M, Brull SJ, Kopman AF, Hunter JM, Fulesdi B, Arkes HR, Elstein A, Todd MM, Johnson KB. Consensus Statement on Perioperative Use of Neuromuscular Monitoring. Anesth Analg. 2018 Jul;127(1):71-80. doi: 10.1213/ANE.0000000000002670.

    PMID: 29200077BACKGROUND

  • Armendariz-Buil I, Lobato-Solores F, Aguilera-Celorrio L, Morros-Diaz E, Fraile-Jimenez E, Vera-Bella J. Residual neuromuscular block in type II diabetes mellitus after rocuronium: a prospective observational study. Eur J Anaesthesiol. 2014 Aug;31(8):411-6. doi: 10.1097/01.EJA.0000435022.91954.8d.

    PMID: 24201596BACKGROUND

  • Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.

    PMID: 17635389BACKGROUND

Related Links

Study Officials

  • Wei Chieh Lai, MD, MPH

    Taipei Medical University Hospital

    STUDY CHAIR

Central Study Contacts

Wei Chieh Lai, MD, MPH

CONTACT

+886919141289ndicy@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 31, 2022

First Posted

March 24, 2022

Study Start

December 20, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2022

Record last verified: 2022-11

Locations

TW(1)