The effect of muscle relaxant drugs on the larynx
ISRCTN | ISRCTN41705277 |
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DOI | https://doi.org/10.1186/ISRCTN41705277 |
Secondary identifying numbers | RBF 96XX4 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 31/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
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
Dr Keith Girling
Scientific
Scientific
University Department of Anaesthesia
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Phone | +44 (0)115 924 9924 Ext 42855 |
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abc@email.com |
Study information
Study design | Randomised crossover study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | The effect of muscle relaxant drugs on the larynx |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Interim and final reports for review by NHS Executive Trent |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/02/1997 |
Completion date | 31/01/1999 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 40 |
Key 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). |
Key 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. |
Date of first enrolment | 01/02/1997 |
Date of final enrolment | 31/01/1999 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Department of Anaesthesia
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Trent (UK)
No information available
Results and Publications
Intention to publish date | |
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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
31/10/2019: No publications found, verifying study status with principal investigator.