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Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection (TURPS)

Primary Purpose

Prostate, Hyperplasia

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
total intravenous anaesthesia
spinal anaesthesia
Sponsored by
Asker & Baerum Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate focused on measuring prostata hyperplasia, transurethral resection, TIVA, spinal anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asker & Baerum Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TIVA

Spinal

Arm Description

Total intravenous anaesthesia (TIVA) with propofol and remifentanil

Spinal anaesthesia with bupivacaine and fentanyl

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

time in PACU
period in post anaesthetic care unit

Full Information

First Posted
April 7, 2010
Last Updated
May 5, 2010
Sponsor
Asker & Baerum Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01118260
Brief Title
Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
Acronym
TURPS
Official Title
TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Asker & Baerum Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate, Hyperplasia
Keywords
prostata hyperplasia, transurethral resection, TIVA, spinal anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIVA
Arm Type
Active Comparator
Arm Description
Total intravenous anaesthesia (TIVA) with propofol and remifentanil
Arm Title
Spinal
Arm Type
Active Comparator
Arm Description
Spinal anaesthesia with bupivacaine and fentanyl
Intervention Type
Procedure
Intervention Name(s)
total intravenous anaesthesia
Intervention Description
propofol and remifentanil
Intervention Type
Procedure
Intervention Name(s)
spinal anaesthesia
Intervention Description
bupivacaine and fentanyl
Primary Outcome Measure Information:
Title
patient satisfaction
Description
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
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
time in PACU
Description
period in post anaesthetic care unit
Time Frame
4 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Dahl, MD, PhD
Organizational Affiliation
Asker & Baerum Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elisabet Andersson
Organizational Affiliation
Asker & Baerum Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asker & Baerum Hospital
City
Rud
ZIP/Postal Code
1309
Country
Norway

12. IPD Sharing Statement

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Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

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