Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
31/08/2012
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

Dr Keith Girling

ORCID ID

Contact details

University Department of Anaesthesia
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 Ext 42855

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RBF 96XX4

Study information

Scientific title

Acronym

Study hypothesis

Phase 1: to compare the degree of neuromuscular block at the larynx using video imaging and endotracheal tube cuff pressure changes.
Phase 2: to compare the onset, duration and recovery index of intubating doses of various commonly used relaxants a the vocal cords and adductor pollicis.
Phase 3: to extend the studies to include monitoring sites other than adductor pollicis (initially the orbicularis oculi and the diaphragm).

Ethics approval

Not provided at time of registration

Study design

Randomised crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Ear, nose and throat diseases

Intervention

Phase I: The patients will be allocated randomly to one of four groups. Group one will have the adductor pollicis twitch reduced by 25%, group two 50%, group three 75% and group four 90%.
Phase II: Patients will be allocated randomly to receive one of five muscle relaxants which have been selected on the basis of their different onset characteristics: group 1 vecuronium 0.08 mg.kg-1; group 2 rocuronium 0.6 mg.kg-1; group 3 atracurium 0.45 mg.kg-1; group 4 suxamethonium 1.0 mg.kg-1; and group 5 mivacurium 0.16 mg.kg-1.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Interim and final reports for review by NHS Executive Trent

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/1997

Overall trial end date

31/01/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Phase 1: 40 patients will be studied in this randomised crossover study. All patients will be scheduled to undergo elective surgery which will require the use of nondepolarizing muscle relaxants.
Phase 2: American Society of Anesthesiologists (ASA) 1&2 patients will be studied initially. Inclusion and exclusion criteria and patient monitoring will be as for Phase 1. Patients will then be allocated randomly to receive one of five muscle relaxants (10 per group). If numbers prove insufficient, further patients will be recruited, in groups of 25 (5 per group).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Any patient with a history of regurgitation, dyspepsia or neuromuscular disease or who is taking any medication that may interfere with neuromuscular function will be excluded.

Recruitment start date

01/02/1997

Recruitment end date

31/01/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Department of Anaesthesia
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Trent (UK)

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