Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0203132060
Study information
Scientific title
Acronym
Study hypothesis
Does general anaesthesia using bolus dosing of remifentanil with propofol, compared with the alfentanil/propofol/isoflurane technique, for short, day-case gynaecological procedures reduce recovery time and improve time to street-fitness and discharge?
To compare two anaesthetic techniques (remifentanil/propofol with the commonly used alfentanil/volatile agent based anaesthetic) in the induction and maintenance of anaesthesia in day case gynaecological surgery. To establish if there are clinical advantages of one technique over the other. We aim to disprove the Null Hypothesis. The Null Hypothesis being tested is that there is no difference in recovery time and time to discharge for patients undergoing short, day-case gynaecological procedures under general anaesthesia using either bolus dosing or remifentanil with propofol or the commonly used alfentanil/propofol/isoflurane technique.
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
Surgery: Anaesthesia
Intervention
To study 60 American Society of Anesthesiologists (ASA) 1 and 2 subjects presenting for routine elective minor gynaecological day case surgery. Subjects will be randomised to two groups A and B.
Group A will act as the control group. They will undergo induction of general anaesthesia with alfentanil and propofol and maintenance of anaesthesia with nitrous oxide and isoflurane.
Group B will be the study group. They will undergo induction of anaesthesia using remifentanil and propofol. Maintenance will be with nitrous oxide and incremental bolus doses of a premixed solution of remifentanil and propofol.
We will observe several aspects of post-operative recovery such as time to eye opening, recollection of name, resumption of spontaneous respiration, fitness for discharge from recovery and readiness for home discharge. We will also look at analgesic requirements and the incidence of nausea and vomiting. The allocation to group A or B will be blinded to the investigator noting the outcome data points.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Time from end of procedure to
1.1. eyes open
1.2. recollection of name
1.3. fitness to discharge from recovery
1.4. ready for home discharge
2. post-operative pain
3. analgesic requirements
4. nausea and vomiting
5. total dose of agents used
Secondary outcome measures
Not provided at time of registration
Overall trial start date
24/10/2003
Overall trial end date
13/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
ASA 1 and 2 subjects presenting for routine elective minor gynaecological day case surgery. All patients attending for surgery will be given a patient information leaflet and those agreeing to participate in the study will be asked to sign a consent form. They will be the subject of therapeutic research.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients giving history of reflux or hiatus hernia, obesity or cases requiring tracheal intubation for any other reason.
Recruitment start date
24/10/2003
Recruitment end date
13/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Devon and Exeter 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
Bolus dosing of Remifentanil with propofol for gynaecological day case surgery. D Melville, EL Hartsilver, A Hart.The Journal of One-Day Surgery 2008;18(4):88-91