Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/07/2009
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 Emma Hartsilver

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes