- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224470
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
-
-
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Seoul, Korea, Republic of, 120-752
- Severance Hospital
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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
|
Dexamedetomidine intravenous injection (1 ㎍/kg )
Other Names:
|
Active Comparator: bupivacaine
0.5% bupivacaine 1.2 mL + normal saline 0.8 mL = total 2 mL
|
Dexamedetomidine intravenous injection (1 ㎍/kg )
Other Names:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
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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