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
Scientific
Department of Anaesthetics & Intensive Care Medicine
Queens' University Belfast
2nd Floor, Mulhouse Building
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Study information
| Study design | Randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | Time to return of TOF (train-of-four) ratio to 0.9 |
| Secondary outcome measures | 1. Tme to onset of block 2. Time to return of T1 to 25% |
| Overall study start date | 01/04/2008 |
| 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 number of participants | 20 patients |
| 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
- Northern Ireland
- United Kingdom
Study participating centre
Queens' University Belfast
Belfast
BT12 6BJ
United Kingdom
BT12 6BJ
United Kingdom
Sponsor information
Belfast Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BJ
Northern Ireland
United Kingdom
| Website | http://www.belfasttrust.hscni.net |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/03/2017: No publications found, verifying study status with principal investigator.
