NCT01118260

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
Last Updated

May 6, 2010

Status Verified

May 1, 2010

Enrollment Period

3.3 years

First QC Date

April 7, 2010

Last Update Submit

May 5, 2010

Conditions

ProstateHyperplasia

Keywords

prostata hyperplasiatransurethral resectionTIVAspinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    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 Outcomes (1)

  • time in PACU

    4 hours

Study Arms (2)

TIVA

ACTIVE COMPARATOR

Total intravenous anaesthesia (TIVA) with propofol and remifentanil

Procedure: total intravenous anaesthesia

Spinal

ACTIVE COMPARATOR

Spinal anaesthesia with bupivacaine and fentanyl

Procedure: spinal anaesthesia

Interventions

total intravenous anaesthesiaPROCEDURE

propofol and remifentanil

TIVA
spinal anaesthesiaPROCEDURE

bupivacaine and fentanyl

Spinal

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • signed informed consent
  • elective transurethral prostata resection

You may not qualify if:

  • ASA more than 3
  • kidney disease, liver disease
  • intolerance against bupivacaine, fentanyl, propofol og remifentanil
  • chronic pulmonary disease
  • dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asker & Baerum Hospital

Rud, 1309, Norway

Location

MeSH Terms

Conditions

Hyperplasia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Vegard Dahl, MD, PhD

    Asker & Baerum Hospital

    STUDY CHAIR

  • Elisabet Andersson

    Asker & Baerum Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

May 6, 2010

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 6, 2010

Record last verified: 2010-05

Locations

NO(1)