Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

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.

Publication citations

Additional files

Editorial Notes