The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

NCT ID: NCT01224470

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic agents result in prolongation of the duration of the sensory and motor blockade induced by hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on the low-dose spinal anesthesia for the transurethral surgery.

Detailed Description

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Conditions

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Transurethral Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bupivacaine

0.5% bupivacaine 1.2 mL + normal saline 0.8 mL = total 2 mL

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexamedetomidine intravenous injection (1 ㎍/kg )

saline

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexamedetomidine intravenous injection (1 ㎍/kg )

Interventions

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Dexmedetomidine

Dexamedetomidine intravenous injection (1 ㎍/kg )

Intervention Type DRUG

Other Intervention Names

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brand name : PRECEDEX (generic name : Dexmedetomidine)

Eligibility Criteria

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Inclusion Criteria

* ASA class I or II
* Elective transurethral prostatectomy
* aged \> 20

Exclusion Criteria

* Coagulation deficiency
* infection on the back
* Congestive heart failure or arrythmia
* Chronic alcoholic disease
* Antidepressants therapy
Minimum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Anesthesiology and Pain Medicine, Severance Hospital

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Hong JY, Kim WO, Yoon Y, Choi Y, Kim SH, Kil HK. Effects of intravenous dexmedetomidine on low-dose bupivacaine spinal anaesthesia in elderly patients. Acta Anaesthesiol Scand. 2012 Mar;56(3):382-7. doi: 10.1111/j.1399-6576.2011.02614.x. Epub 2012 Jan 4.

Reference Type DERIVED
PMID: 22220945 (View on PubMed)

Other Identifiers

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4-2010-0405

Identifier Type: -

Identifier Source: org_study_id

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