ProstatePhase 4TURPSNCT01118260
Total Intravenous Anaesthesia (TIVA) Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
A Phase 4 study testing total intravenous anaesthesia and spinal anaesthesia in people with Prostate and Hyperplasia, run by Asker & Baerum Hospital at 1 site in Norway.
Trial summary
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate, Hyperplasia
- What is being tested?
- total intravenous anaesthesia and spinal anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- signed informed consent
- elective transurethral prostata resection
Who cannot join
- ASA more than 3
- kidney disease, liver disease
- intolerance against bupivacaine, fentanyl, propofol og remifentanil
- chronic pulmonary disease
- dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection
Read the detailed description
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time
- Conditions
- Prostate, Hyperplasia
- Being tested
- total intravenous anaesthesia, spinal anaesthesia
- Keywords
- prostata hyperplasia, transurethral resection, TIVA, spinal anaesthesia
- Medical subject headings
- Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total intravenous anaesthesiaProcedure or surgery
propofol and remifentanil
spinal anaesthesiaProcedure or surgery
bupivacaine and fentanyl
| Study group | Role | What they receive |
|---|---|---|
| TIVA | Active comparator | Total intravenous anaesthesia (TIVA) with propofol and remifentanil Receives: Procedure: total intravenous anaesthesia |
| Spinal | Active comparator | Spinal anaesthesia with bupivacaine and fentanyl Receives: Procedure: spinal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
Secondary outcomes (1)
time in PACU
period in post anaesthetic care unit
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asker & Baerum Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vegard Dahl, MD, PhD, Study chair, Asker & Baerum HospitalElisabet Andersson, Principal investigator, Asker & Baerum Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118260
- Sponsor's protocol ID
- 2004-002672-42
- Other IDs
- 2004
- Acronym
- TURPS
- Status last verified
- May 2010
- First submitted
- 7 Apr 2010
- Last updated
- 6 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIVA Versus Spinal Anaesthesia in Patients Undergoing Transurethral Prostate Resection
- ClinicalTrials.gov ID
- NCT01118260
- Acronym / sponsor ID
- TURPS / 2004-002672-42
- Conditions
- Prostate, Hyperplasia
- Keywords
- prostata hyperplasia, transurethral resection, TIVA, spinal anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Asker & Baerum HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection
Detailed description
Comparison of total intravenous anaesthesia with spinal anaesthesia in patients undergoing transurethral prostate resection regarding patient satisfaction and discharge time
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIVA | Active comparator | Procedure: total intravenous anaesthesiaTotal intravenous anaesthesia (TIVA) with propofol and remifentanil |
| Spinal | Active comparator | Procedure: spinal anaesthesiaSpinal anaesthesia with bupivacaine and fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- signed informed consent
- elective transurethral prostata resection
Key exclusion criteria (5 listed)
- ASA more than 3
- kidney disease, liver disease
- intolerance against bupivacaine, fentanyl, propofol og remifentanil
- chronic pulmonary disease
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total intravenous anaesthesiapropofol and remifentanil | Procedure or surgery | TIVA |
| spinal anaesthesiabupivacaine and fentanyl | Procedure or surgery | Spinal |
Primary outcome
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
1 secondary outcome
time in PACU
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Dahl, MD, PhD study chair
Asker & Baerum Hospital
Elisabet Andersson principal investigator
Asker & Baerum Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing total intravenous anaesthesia and spinal anaesthesia in people with Prostate and Hyperplasia, run by Asker & Baerum Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2010.