Target-controlled sedation versus 'low-dose' spinal anesthesia in tension-free suburethral sling surgery for stress incontinence.
ISRCTN | ISRCTN64888483 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN64888483 |
Secondary identifying numbers | N0047111207 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 24/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Toozs-Hobson
Scientific
Scientific
Birmingham Women's Hospital
Uro-gynaecology Department
Edgbaston
Birmingham
B15 2TG
United Kingdom
Phone | +44 (0)121 472 1377 ext 4707 |
---|
Study information
Study design | Randomised double-bind study |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | NN/A |
Study objectives | We propose a randomised, double-bind study to compare both anaesthetic techniques (target-controlled sedation and 'low-dose' spinal anaesthesia). |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Urological and Genital Diseases: Stress incontinence |
Intervention | Each volunteer will be studied for the duration of the operation, until completion of the post-operative questionnaire and urodynamic studies, 3 h postoperatively. The average length of the procedure is 45 min. The only additional invasive procedure that would not be part of the routine is the subcutaneous local anaesthetic injection of 2 ml Lignocaine 1% in the back of the volunteers randomised into the propofol target controlled sedation group for the purpose of blinding. |
Intervention type | Other |
Primary outcome measure | Outcomes will be assessed by indices of patient satisfaction, satisfaction for surgical conditions, perioperative sedation scores, oxygenation, haemodynamic variables and the impact of anaesthetic technique on return of bladder sensation. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/06/2002 |
Completion date | 30/09/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Female |
Target number of participants | 50 |
Key inclusion criteria | Patients will be recruited from the clinical gynaelogical practice of Mr P Toozs-Hobson and Mr Emens. Individuals scheduled for suburethral sling surgery will be invited to participate in the investigation. Written consent will be obtained in all cases. We aim to recruit 25 patients to each arm of the study. Inclusion criteria: first operative procedure for stress incontinence. |
Key exclusion criteria | 1. Contradiction to spinal anaesthesia 2. Unable/unwilling to give consent 3. Significant respiratory/cardiovascular disease/epilepsy 4. Allergy to propofol, opioids and local anaesthetics |
Date of first enrolment | 01/06/2002 |
Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom
B15 2TG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
---|
Funders
Funder type
Government
Birmingham Women's Healthcare 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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/07/2010 | Yes | No |