Bolus Dosing of Remifentanil with Propofol for Gynaecological Day Case Surgery

ISRCTN	ISRCTN27187868
DOI	https://doi.org/10.1186/ISRCTN27187868
Secondary identifying numbers	N0203132060

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 09/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Emma Hartsilver
Scientific

Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Bolus Dosing of Remifentanil with Propofol for Gynaecological Day Case Surgery
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	24/10/2003
Completion date	13/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Patients giving history of reflux or hiatus hernia, obesity or cases requiring tracheal intubation for any other reason.
Date of first enrolment	24/10/2003
Date of final enrolment	13/07/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Devon & Exeter Hospital (Wonford)

Exeter
EX2 5DW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Royal Devon and Exeter NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

09/08/2021: Internal review.