Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0084118520
Study information
Scientific title
A comparison of the effects of remifentanil infusion compared with conventional anaesthesia on postoperative pain in patients undergoing spinal surgery
Acronym
Study hypothesis
To compare postoperative analgesia requirements in patients receiving anaesthesia with remifentanil and those receiving conventional anaesthesia.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Signs and Symptoms: Pain, sedation, nausea, vomiting
Intervention
1. Conventional anaesthesia
2. Total intravenous anaesthesia
Intervention type
Drug
Phase
Not Specified
Drug names
Primary outcome measures
Pain, sedation, nausea and vomiting scores recorded hourly for 8 h after surgery - this is routine.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
15/11/2002
Overall trial end date
01/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
A sample size of 31 patients in each group, presenting for spinal surgery is desired
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
62
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
15/11/2002
Recruitment end date
01/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
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
The North and South Bank Research and Development Consortium (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