A prospective randomised, double-blind, placebo controlled trial to assess the respiratory effects of buprenorphine versus morphine in anaethetised patients

ISRCTN ISRCTN41174967
DOI https://doi.org/10.1186/ISRCTN41174967
Secondary identifying numbers N0205120616
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
21/07/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R Langford
Scientific

Department of Anaesthetics
Royal London Hospital
Whitechapel Rd
London
E1 1BB
United Kingdom

Phone +44 (0)20 7377 7793
Email r.m.langford@qmul.ac.uk

Study information

Study designRandomised double-blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesThis 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Anaesthesia
InterventionBuprenorphine and morphine vs placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)buprenorphine and morphine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date07/02/2003
Completion date31/07/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsAim to recruit 90 patients.
Key inclusion criteriaPatients that will have an operation lasting more than 30 min that require general anaesthetic, from Barts Hospital main theatres.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment07/02/2003
Date of final enrolment31/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthetics
London
E1 1BB
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Barts and The London NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results The study was presented to and accepted by the Anaesthetic Research Society, UK in December - 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 02/03/2008 No No