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

• Sponsor: Asker & Baerum Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01118260
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostate; Hyperplasia	Procedure: total intravenous anaesthesia; Procedure: spinal anaesthesia	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• 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
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. patient satisfaction [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

1. time in PACU [4 hours]

   period in post anaesthetic care unit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01118260
• Other Study ID Numbers: 2004-002672-42
• First Posted: May 6, 2010
• Last Update Posted: May 6, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: prostata hyperplasia; transurethral resection; TIVA; spinal anaesthesia
• Additional relevant MeSH terms: Hyperplasia; Anesthetics

Study Results

No Results Posted as of May 6, 2010