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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list