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
Protocol serial number	N0047111207
Sponsor	Department of Health (UK)
Funder	Birmingham Women's Healthcare NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised double-bind study
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	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

Birmingham Women's Hospital

Birmingham
B15 2TG
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No