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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01224470
First received: October 19, 2010
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention
Transurethral Prostatectomy
 Drug: Dexmedetomidine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Enrollment: 51
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bupivacaine
0.5% bupivacaine 1.2 mL + normal saline 0.8 mL = total 2 mL
 Drug: Dexmedetomidine
Dexamedetomidine intravenous injection (1 ㎍/kg )
Other Names:
  • brand name : PRECEDEX
  • (generic name : Dexmedetomidine)
Placebo Comparator: saline Drug: Dexmedetomidine
Dexamedetomidine intravenous injection (1 ㎍/kg )
Other Names:
  • brand name : PRECEDEX
  • (generic name : Dexmedetomidine)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224470

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hae Keum Kil / Professor, Anesthesiology and Pain Medicine, Severance Hospital
ClinicalTrials.gov Identifier: NCT01224470     History of Changes
Other Study ID Numbers: 4-2010-0405
Study First Received: October 19, 2010
Last Updated: April 27, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
 Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013