The effect of muscle relaxant drugs on the larynx

ISRCTN	ISRCTN41705277
DOI	https://doi.org/10.1186/ISRCTN41705277
Protocol serial number	RBF 96XX4
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Trent (UK)

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

Dr Keith Girling
Scientific

University Department of Anaesthesia
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 924 9924 Ext 42855
Email	abc@email.com

Primary study design	Interventional
Study design	Randomised crossover study
Secondary study design	Randomised controlled trial
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(s)	Interim and final reports for review by NHS Executive Trent
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/01/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

University Department of Anaesthesia

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

31/10/2019: No publications found, verifying study status with principal investigator.