Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gilbert R Park

ORCID ID

Contact details

Box 17
John Farman Intensive Care Unit
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217433
gilbertpark@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0287042181

Study information

Scientific title

Sedation using sevoflurane during spinal anaesthesia. A single centre, double blind, randomised, placebo controlled study

Acronym

Study hypothesis

Sedation using sevoflurane during spinal anaesthesia

Ethics approval

Not provided at time of registration

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Spinal anaesthesia

Intervention

We aim to compare two groups of patients undergoing spinal anaesthesia. Both groups will receive identical spinal anaesthesia. In addition, one group will receive an inhalational anaesthetic, sevoflurane, as a sedative agent. The second group (control group) will not receive additional sedation.

The patients will be visited before the operation and the technique explained to them. Two anaesthetists will be present during the procedure (anaesthetist A and anaesthetist B). In the anaesthetic room an intravenous cannula will be inserted and a spinal block performed using a 25 gauge needle and 0.5% hyperbaric bupivacaine.

Five patients will be randomly allocated into the sevoflurane or placebo (oxygen/air) group (25 in each). All patients will receive 2 l/min oxygen/air mixture from the anaesthetic machine through nasal cannulae. The anaesthetic machine will be covered so that only anaesthetist A will be able to see the sevoflurane vaporiser. He will add a fixed percentage of sevoflurane (at the moment thought to be 1-2%, but may need to be greater) to the fresh gas flow for patients allocated to the sedation group. The vaporiser will remain turned off for the non-sedation group.

Anaesthetist B will be responsible for assessing levels of sedation at all points during the anaesthetic and recovery phase. This will involve several well recognised psychomotor tests, including the Ramsay Sedation Scale, Trieger's adaptation of the Bender Motor Gestalt Test, and also a tapping test and ball bearing test as used by previous investigators including Short and Galletly. Before anaesthesia, Anaesthetist B will explain the test to the patient. The patient will be visited three times after the operation. First on the recovery ward, and later on the main ward at 4 h and 24 h after the operation. During these visits, the Trieger, tapping and ball bearing tests will be repeated and the patient will be asked to give a satisfaction rating based on a 10-cm visual analogue scale.

Intervention type

Drug

Phase

Not Specified

Drug names

Sevoflurane

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

21/05/1999

Overall trial end date

20/05/2003

Reason abandoned

Lack of funding/sponsorship

Eligibility

Participant inclusion criteria

27 (ACT)(COMP)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

27

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

21/05/1999

Recruitment end date

20/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box 17
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Other

Funder name

Cambridge Consortium - Addenbrookes (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

Publication citations

Additional files

Editorial Notes