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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014