Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000353
Study information
Scientific title
Comparison of neuromuscular monitoring in the dominant and non-dominant hand using the TOF-Watch® SX: a single-centre randomised controlled trial
Acronym
Study hypothesis
Is there a difference in the response observed between the dominant and non-dominant hand when using acceleromyography to monitor neuromuscular blockade?
Ethics approval
Health and Social Care Research Ethics Committee (HSC REC 3) (Northern Ireland), 23/07/2009, ref: 07/NIR03/1
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/04/2008
Overall trial end date
01/04/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. American Society of Anaesthesiologists (ASA) grade I - III
2. Aged 18 - 65 years, either sex
3. Undergoing planned, elective surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20 patients
Participant 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
Recruitment start date
01/04/2008
Recruitment end date
01/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queens' University Belfast
Belfast
BT12 6BJ
United Kingdom
Sponsor information
Organisation
Belfast Health and Social Care Trust (UK)
Sponsor details
Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Belfast Health and Social Care Trust (UK) (ref: RGHT000353)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list