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The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01175746
Recruitment Status : Completed
First Posted : August 5, 2010
Last Update Posted : June 13, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Nicardipine Drug: remifentanil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: nicardipine Drug: Nicardipine
Active Comparator: remifentanil Drug: remifentanil
0.1-0.5 ugkg/min during hypotensive anesthesia
Other Name: ultiva®


Outcome Measures
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Primary Outcome Measures :
  1. Creatinine Clearance [ Time Frame: 2hr after the start of hypotensive anesthesia ]

    Hypotensive anesthesia means that we maintain the mean blood pressure between 55 & 65 mmHg during surgery to decrease the blood loss.

    The specific time point is exactly 2hr after we star to lower the blood pressure.



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult patients undergoing hypotensive anesthesia

Exclusion Criteria:

  • patients with any co-morbidity
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175746


Sponsors and Collaborators
Yonsei University
Investigators
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Principal Investigator: Ji Young Kim Severance hospital, YUHS
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01175746    
Other Study ID Numbers: 3-2009-0196
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: June 13, 2013
Last Verified: June 2013
Keywords provided by Yonsei University:
healthy adult patients
ASA class I
hypotensive anesthesia
Additional relevant MeSH terms:
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Nicardipine
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents