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

This study has been completed.
Sponsor:
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT01118260
First received: April 7, 2010
Last updated: May 5, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • patient satisfaction [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 7, 2010
Last Updated: May 5, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agencies

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014