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
Protocol serial number	RGHT000353
Sponsor	Belfast Health and Social Care Trust (UK)
Funder	Belfast Health and Social Care Trust (UK) (ref: 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

Primary study design	Interventional
Study design	Randomised controlled single-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparison of neuromuscular monitoring in the dominant and non-dominant hand using the TOF-Watch® SX: a single-centre randomised controlled trial
Study objectives	Is 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) studied	Routine surgery/neuromuscular block
Intervention	After 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 type	Procedure/Surgery
Primary outcome measure(s)	Time to return of TOF (train-of-four) ratio to 0.9
Key secondary outcome measure(s)	1. Tme to onset of block 2. Time to return of T1 to 25%
Completion date	01/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. American Society of Anaesthesiologists (ASA) grade I - III 2. Aged 18 - 65 years, either sex 3. Undergoing planned, elective surgery
Key exclusion criteria	1. 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 enrolment	01/04/2008
Date of final enrolment	01/04/2009

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Queens' University Belfast

Belfast
BT12 6BJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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