Sedation using sevoflurane during spinal anaesthesia.
| ISRCTN | ISRCTN36581428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36581428 |
| Protocol serial number | N0287042181 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrookes (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 18/11/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Gilbert R Park
Scientific
Scientific
Box 17
John Farman Intensive Care Unit
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 217433 |
|---|---|
| gilbertpark@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind placebo controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Sedation using sevoflurane during spinal anaesthesia. A single centre, double blind, randomised, placebo controlled study |
| Study objectives | Sedation using sevoflurane during spinal anaesthesia |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Sevoflurane |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 20/05/2003 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 27 |
| Key inclusion criteria | 27 (ACT)(COMP) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 21/05/1999 |
| Date of final enrolment | 20/05/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box 17
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
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 |
