Contact information
Type
Scientific
Primary contact
Dr R Langford
ORCID ID
Contact details
Department of Anaesthetics
Royal London Hospital
Whitechapel Rd
London
E1 1BB
United Kingdom
+44 (0)20 7377 7793
r.m.langford@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0205120616
Study information
Scientific title
Acronym
Study hypothesis
This study is designed to investigate the effects of buprenorphine and morphine on respiratory parameters and in the event of changes occurring, the use of reversibility by naloxone (an opioid antagonist).
Ethics approval
Not provided at time of registration
Study design
Randomised double-blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
Buprenorphine and morphine vs placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
buprenorphine and morphine
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/02/2003
Overall trial end date
31/07/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients that will have an operation lasting more than 30 min that require general anaesthetic, from Barts Hospital main theatres.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Aim to recruit 90 patients.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
07/02/2003
Recruitment end date
31/07/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthetics
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barts and The London NHS Trust (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
The study was presented to and accepted by the Anaesthetic Research Society, UK in December 2004 - Meeting in Leeds. The published abstract is cited as: Mehta V, Phillips JP, Wantman AC, Ratcliffe SH, van Raders PA, Langford RM. Investigation of buprenorphine induced respiratory depression in anaesthetised patients and its reversibility. British J Anaesthesia. 2005; 94: 399-400. See http://bja.oxfordjournals.org/cgi/reprint/94/3/399P?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=Mehta+V&searchid=1&FIRSTINDEX=0&volume=94&issue=3&resourcetype=HWCIT.