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

April 27, 2011 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline
Drug: Dexmedetomidine
Dexamedetomidine intravenous injection (1 ㎍/kg )
Other Names:
  • brand name : PRECEDEX
  • (generic name : Dexmedetomidine)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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