Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.
TURP
Low Dose, Low Concentration Different Baricity Bupivacaine for Transuretral Prostatectomy.
1 other identifier
interventional
52
1 country
1
Brief Summary
Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities.
- Group I: low dose isobaric group
- GroupII: Low dose hyperbaric group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMay 23, 2013
May 1, 2013
2 months
May 15, 2013
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spinal Block Quality
Sensory block assesment with pinpric test.
15 minute after intrathecal injection
Secondary Outcomes (1)
Spinal block regression
5 minute after arrival at PACU
Study Arms (2)
Heavy Bupivacain, Local anesthetic, Amp
EXPERIMENTALHeavy bupivacaine 7.5 mg (1.5 ml), 20 microgram fentanyl(0.4 ml), 1.1 ml saline , Total 3 ml
Isobaric spinal, Local anesthetic, Amp
ACTIVE COMPARATOR7,5 mg isobaric bupivacaine, 20 microgram (0.4 ml)fentanyl, 1.1 ml saline, Total 3 ml
Interventions
7,5 mg intrathecal hyperbaric bupivacain,
7.5 mg intratecal isobaric bupivacain
Eligibility Criteria
You may qualify if:
- years ASA 1-4 BENİGN PROSTAT HYPERPLASİ
You may not qualify if:
- Allergy of study drugs
- Morbid obesity
- Spinal anesthesia contrindications
- Bleeding dyscrasias
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Education and Research Hospital
Ankara, 06610, Turkey (Türkiye)
Related Publications (2)
Loubert C, Hallworth S, Fernando R, Columb M, Patel N, Sarang K, Sodhi V. Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study. Anesth Analg. 2011 Oct;113(4):811-7. doi: 10.1213/ANE.0b013e3182288bf2. Epub 2011 Sep 2.
PMID: 21890887BACKGROUNDKim SY, Cho JE, Hong JY, Koo BN, Kim JM, Kil HK. Comparison of intrathecal fentanyl and sufentanil in low-dose dilute bupivacaine spinal anaesthesia for transurethral prostatectomy. Br J Anaesth. 2009 Nov;103(5):750-4. doi: 10.1093/bja/aep263. Epub 2009 Sep 28.
PMID: 19797249BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MURAT M SAYIN, Ass. Prof
Dispapi yildirim beyazit E R hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 15, 2013
First Posted
May 23, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
May 23, 2013
Record last verified: 2013-05