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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01118260
Other study ID # 2004-002672-42
Secondary ID
Status Completed
Phase Phase 4
First received April 7, 2010
Last updated May 5, 2010
Start date January 2006
Est. completion date May 2009

Study information

Verified date May 2010
Source Asker & Baerum Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agencies
Study type Interventional

Clinical Trial Summary

Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection


Description:

Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and older

- signed informed consent

- elective transurethral prostata resection

Exclusion Criteria:

- ASA more than 3

- kidney disease, liver disease

- intolerance against bupivacaine, fentanyl, propofol og remifentanil

- chronic pulmonary disease

- dementia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
total intravenous anaesthesia
propofol and remifentanil
spinal anaesthesia
bupivacaine and fentanyl

Locations

Country Name City State
Norway Asker & Baerum Hospital Rud

Sponsors (1)

Lead Sponsor Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary patient satisfaction Patient satisfaction was measured asking the patient about satisfaction with anaesthesia using a 5-point Linkert scale: totally satisfied - satisfied - neither satisfied nor dissatisfied - dissatisfied - totally dissatisfied Time frame: Start anaesthesia to end post anaesthestic care unit 4 hours No
Secondary time in PACU period in post anaesthetic care unit 4 hours No
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