Comparison of the response observed in the dominant and non-dominant hands when assessing neuromuscular block using the TOF-Watch® SX

ISRCTN ISRCTN82219498
DOI https://doi.org/10.1186/ISRCTN82219498
Secondary identifying numbers RGHT000353
Submission date
30/09/2009
Registration date
14/10/2009
Last edited
07/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Rosemary Hogg
Scientific

Department of Anaesthetics & Intensive Care Medicine
Queens' University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom

Study information

Study designRandomised controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleComparison of neuromuscular monitoring in the dominant and non-dominant hand using the TOF-Watch® SX: a single-centre randomised controlled trial
Study objectivesIs there a difference in the response observed between the dominant and non-dominant hand when using acceleromyography to monitor neuromuscular blockade?
Ethics approval(s)Health and Social Care Research Ethics Committee (HSC REC 3) (Northern Ireland), 23/07/2009, ref: 07/NIR03/1
Health condition(s) or problem(s) studiedRoutine surgery/neuromuscular block
InterventionAfter pre-oxygenation, all patients will receive a standard anaesthetic regimen consisting of intravenous infusions of propofol (0.1 - 8.0 µg/ml) and remifentanil (0.1 - 1.0 µg/kg/min) for induction and maintenance of anaesthesia. After induction, monitoring will be commenced on both arms using the TOF-Watch® SX. The monitors will be applied to the skin over the ulnar nerve at the wrist and calibrated according to Good Clinical Research Practice guidelines. After stabilisation of the TOF-Watch® SX trace in both arms, rocuronium (0.6 mg/kg) will be administered, following which tracheal intubation will be performed.

Surgery will be continued as normal with monitoring continuing until extubation. Reversal with neostigmine will be performed as required.
Intervention typeProcedure/Surgery
Primary outcome measureTime to return of TOF (train-of-four) ratio to 0.9
Secondary outcome measures1. Tme to onset of block
2. Time to return of T1 to 25%
Overall study start date01/04/2008
Completion date01/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants20 patients
Key inclusion criteria1. American Society of Anaesthesiologists (ASA) grade I - III
2. Aged 18 - 65 years, either sex
3. Undergoing planned, elective surgery
Key exclusion criteria1. Patients with known neuromuscular disease
2. Patients on medication known to interact with neuromuscular blocking agents
3. Pregnancy
4. Patients with known allergy to neuromuscular blocking agents
5. Patients with a known or suspected risk of difficult intubation
Date of first enrolment01/04/2008
Date of final enrolment01/04/2009

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Queens' University Belfast
Belfast
BT12 6BJ
United Kingdom

Sponsor information

Belfast Health and Social Care Trust (UK)
Hospital/treatment centre

Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BJ
Northern Ireland
United Kingdom

Website http://www.belfasttrust.hscni.net
ROR logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

Government

Belfast Health and Social Care Trust (UK) (ref: RGHT000353)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

07/03/2017: No publications found, verifying study status with principal investigator.