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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01118260
First Posted: May 6, 2010
Last Update Posted: May 6, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asker & Baerum Hospital
  Purpose
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection

Condition Intervention Phase
Prostate Hyperplasia Procedure: total intravenous anaesthesia Procedure: spinal anaesthesia Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

Resource links provided by NLM:


Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • patient satisfaction [ Time Frame: 4 hours ]
    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 [ Time Frame: 4 hours ]
    period in post anaesthetic care unit


Enrollment: 101
Study Start Date: January 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TIVA
Total intravenous anaesthesia (TIVA) with propofol and remifentanil
Procedure: total intravenous anaesthesia
propofol and remifentanil
Active Comparator: Spinal
Spinal anaesthesia with bupivacaine and fentanyl
Procedure: spinal anaesthesia
bupivacaine and fentanyl

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118260


Locations
Norway
Asker & Baerum Hospital
Rud, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
Study Chair: Vegard Dahl, MD, PhD Asker & Baerum Hospital
Principal Investigator: Elisabet Andersson Asker & Baerum Hospital
  More Information

Responsible Party: Dr. med. Vegard Dahl, Asker & Baerum Hospital, Vestre Viken HF
ClinicalTrials.gov Identifier: NCT01118260     History of Changes
Other Study ID Numbers: 2004-002672-42
First Submitted: April 7, 2010
First Posted: May 6, 2010
Last Update Posted: May 6, 2010
Last Verified: May 2010

Keywords provided by Asker & Baerum Hospital:
prostata hyperplasia
transurethral resection
TIVA
spinal anaesthesia

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs