Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of spinal anaesthesia with 1.0 mL hyperbaric bupivacaine 0.5% and total intravenous anaesthesia for minor anorectal surgery
Acronym
Study hypothesis
Minor anorectal surgery can be performed with several anaesthesia techniques. Due to multiple irrational fears, many patients deny a spinal anaesthesia and prefer a general anaesthesia. In this study we evaluate the practicability, patients' acceptability and analgetic consumption for both anaesthesia techniques in patients undergoing minor anorectal surgery.
Ethics approval
Ethics approval received from the local medical ethics committee (Medizinische Ethikkommission II Anschrift: Medizinische Ethik-Kommission II) on the 24th May 2007 (ref: 2007-085N-MA).
Study design
Single-centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Minor anorectal surgery
Intervention
Patients with anorectal surgery are 1:1 randomised to either a spinal anaesthesia or a general anaesthesia. All patients received either:
1. A spinal anaesthesia with 1.0 mL hyperbaric bupivacaine 0.5% or
2. A total intravenous anaesthesia with:
2.1. 0.2 mg fentanyl and 2 mg propofol 1% per kg body weight for induction
2.2. Propofol 1% in a perfusion pump for the duration of anaesthesia, dosage depending on the demands of the patient
2.3. A laryngeal mask (size depending on the body weight of the patient)
Intervention type
Drug
Phase
Not Specified
Drug names
Fentanyl, propofol, bupivacaine
Primary outcome measures
Recovery room time, measured on day of surgery.
Secondary outcome measures
Consumption of analgetics in the first 24 hours, measured 48 hours after surgery.
Overall trial start date
01/09/2007
Overall trial end date
01/02/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients (male/female) with minor anorectal surgery
2. Operation in jack knife position
3. Age: 18 - 75 years
4. American Society of Anaesthesiologists (ASA) grade I - II
5. No contra-indication against spinal anaesthesia or general anaesthesia
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. Contra-indications against spinal anaesthesia or general anaesthesia
2. Operations in prone position
3. Allergy against diclofenac
Recruitment start date
01/09/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic of Anaesthesiology and Critical Care Medicine
Mannheim
68167
Germany
Sponsor information
Organisation
University Hospital Mannheim (Germany)
Sponsor details
Clinic of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
marc.schmittner@anaes.ma.uni-heidelberg.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Germany)
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
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19937984
Publication citations
-
Results
Schmittner MD, Schreiber H, Janke A, Weiss C, Blunk J, Bussen DG, Luecke T, Randomized clinical trial of perianal surgery performed under spinal saddle block versus total intravenous anaesthesia., Br J Surg, 2010, 97, 1, 12-20, doi: 10.1002/bjs.6792.