Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0047111207
Study information
Scientific title
Acronym
NN/A
Study hypothesis
We propose a randomised, double-bind study to compare both anaesthetic techniques (target-controlled sedation and 'low-dose' spinal anaesthesia).
Ethics approval
Not provided at time of registration
Study design
Randomised double-bind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/06/2002
Overall trial end date
30/09/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
50
Participant 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
Recruitment start date
01/06/2002
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Birmingham Women's Hospital
Birmingham
B15 2TG
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Birmingham Women's Healthcare 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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20701511
Publication citations
-
Results
Foon R, Toozs-Hobson P, Cooper G, Anaesthesia for incontinence surgery: spinal anaesthesia or sedation?, J Obstet Gynaecol, 2010, 30, 6, 605-608, doi: 10.3109/01443615.2010.497876.