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

Birmingham Women's Hospital
Uro-gynaecology Department
Edgbaston
Birmingham
B15 2TG
United Kingdom

Phone +44 (0)121 472 1377 ext 4707

Study information

Study designRandomised double-bind study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymNN/A
Study objectivesWe 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) studiedUrological and Genital Diseases: Stress incontinence
InterventionEach 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 typeOther
Primary outcome measureOutcomes 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 measuresNot provided at time of registration
Overall study start date01/06/2002
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants50
Key inclusion criteriaPatients 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 criteria1. 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 enrolment01/06/2002
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom

Sponsor information

Department of Health (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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