Condition category
Surgery
Date applied
30/09/2009
Date assigned
14/10/2009
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rosemary Hogg

ORCID ID

Contact details

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

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 below 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 measures

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

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

Department of Anaesthetics & Intensive Care Medicine
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

http://www.belfasttrust.hscni.net

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes