NCT01224470

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

2 months

First QC Date

October 19, 2010

Last Update Submit

April 27, 2011

Conditions

Transurethral Prostatectomy

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

saline

PLACEBO COMPARATOR
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexamedetomidine intravenous injection (1 ㎍/kg )

Also known as: brand name : PRECEDEX, (generic name : Dexmedetomidine)
bupivacainesaline

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Coagulation deficiency
  • infection on the back
  • Congestive heart failure or arrythmia
  • Chronic alcoholic disease
  • Antidepressants therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 22220945DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2010

First Posted

October 20, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

KR(1)