Bolus Dosing of Remifentanil with Propofol for Gynaecological Day Case Surgery
| ISRCTN | ISRCTN27187868 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27187868 |
| Protocol serial number | N0203132060 |
| Sponsor | Department of Health |
| Funder | Royal Devon and Exeter NHS Trust (UK) |
- 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
Scientific
Royal Devon & Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Time from end of procedure to |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 13/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| 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
- United Kingdom
- England
Study participating centre
Royal Devon & Exeter Hospital (Wonford)
Exeter
EX2 5DW
United Kingdom
EX2 5DW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/08/2021: Internal review.
