Condition category
Surgery
Date applied
23/08/2010
Date assigned
17/05/2011
Last edited
17/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marc Schmittner

ORCID ID

Contact details

Clinic of Anaesthesiology and Critical Care Medicine
University Hospital Mannheim
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
marc.schmittner@umm.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of spinal anaesthesia with 1.5 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 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

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)

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

Not available in web format, please use contact details below to request a 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 1.5 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

Phase

Not Applicable

Drug names

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

01/07/2010

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Contra-indications against spinal anaesthesia or general anaesthesia
2. Allergy against diclofenac

Recruitment start date

01/07/2010

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Clinic of Anaesthesiology and Critical Care Medicine
Mannheim
68167
Germany

Sponsor information

Organisation

University Hospital Mannheim (Gernany)

Sponsor details

c/o Marc D. Schmittner
MD
Clinic of Anaesthesiology and Critical Care Medicine
Theodor-Kutzer-Ufer 1-3
Mannheim
68167
Germany
marc.schmittner@umm.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Mannheim (Gernany)

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

Publication citations

Additional files

Editorial Notes