Spinal anaesthesia or general anaesthesia for anorectal surgery
| ISRCTN | ISRCTN41981381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41981381 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/12/2007
- Registration date
- 20/03/2008
- Last edited
- 05/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Thomas Luecke
Scientific
Scientific
Clinic of Anaesthesiology and Critical Care Medicine
University Hospital Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
Study information
| Study design | Single-centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of spinal anaesthesia with 1.0 mL hyperbaric bupivacaine 0.5% and total intravenous anaesthesia for minor anorectal surgery |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fentanyl, propofol, bupivacaine |
| Primary outcome measure | 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 study start date | 01/09/2007 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key exclusion criteria | 1. Contra-indications against spinal anaesthesia or general anaesthesia 2. Operations in prone position 3. Allergy against diclofenac |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Clinic of Anaesthesiology and Critical Care Medicine
Mannheim
68167
Germany
68167
Germany
Sponsor information
University Hospital Mannheim (Germany)
Hospital/treatment centre
Hospital/treatment centre
Clinic of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
| marc.schmittner@anaes.ma.uni-heidelberg.de | |
"ROR" |
https://ror.org/05sxbyd35 |
Funders
Funder type
Other
Investigator initiated and funded (Germany)
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 | 01/01/2010 | Yes | No |
