Spinal anaesthesia or general anaesthesia for surgery of pilonidal fistula
| ISRCTN | ISRCTN28052769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28052769 |
| Protocol serial number | N/A |
| Sponsor | University Hospital Mannheim (Gernany) |
| Funder | University Hospital Mannheim (Gernany) |
- Submission date
- 23/08/2010
- Registration date
- 17/05/2011
- Last edited
- 17/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Marc Schmittner
Scientific
Scientific
Clinic of Anaesthesiology and Critical Care Medicine
University Hospital Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
| marc.schmittner@umm.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of spinal anaesthesia with 1.5 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 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. Further reading: 2010 results of related trial [ISRCTN41981381] in http://www.ncbi.nlm.nih.gov/pubmed/19937984 |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee (Medizinische Ethikkommission II Anschrift: Medizinische Ethik-Kommission II) on the 18th March 2010 (ref: 2010-215N-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 1.5 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. An orotracheal intubation |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Recovery room time, measured on day of surgery. |
| Key secondary outcome measure(s) |
Consumption of analgetics in the first 24 hours, measured 48 hours after surgery. |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients (male/female) with minor anorectal surgery 2. Operation in prone position 3. Age: 18 - 80 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. Allergy against diclofenac |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Clinic of Anaesthesiology and Critical Care Medicine
Mannheim
68167
Germany
68167
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
