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

May 5, 2010 updated by: Asker & Baerum Hospital

TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Rud, Norway, 1309
        • Asker & Baerum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time in PACU
Time Frame: 4 hours
period in post anaesthetic care unit
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asker & Baerum Hospital

Investigators

  • Study Chair: Vegard Dahl, MD, PhD, Asker & Baerum Hospital
  • Principal Investigator: Elisabet Andersson, Asker & Baerum Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

April 7, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (ESTIMATE)

May 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2010

Last Update Submitted That Met QC Criteria

May 5, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-002672-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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