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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Yonsei University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01175746
First received: August 2, 2010
Last updated: September 27, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention
Healthy Subjects
 Drug: Nicardipine
Drug: remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Creatinine Clearance [ Time Frame: 2hr after the start of hypotensive anesthesia ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 46
Study Start Date: August 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nicardipine Drug: Nicardipine
Active Comparator: remifentanil Drug: remifentanil
0.1-0.5 ugkg/min during hypotensive anesthesia
Other Name: ultiva®

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult patients undergoing hypotensive anesthesia

Exclusion Criteria:

  • patients with any co-morbidity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175746

Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Ji Young Kim Severance hospital, YUHS
  More Information

No publications provided

Responsible Party: Ji Young Kim/assistant professor, Severance Hospital, YUHS
ClinicalTrials.gov Identifier: NCT01175746     History of Changes
Other Study ID Numbers: 3-2009-0196
Study First Received: August 2, 2010
Last Updated: September 27, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
healthy adult patients
ASA class I
hypotensive anesthesia

Additional relevant MeSH terms:
Antihypertensive Agents
Anesthetics
Remifentanil
Nicardipine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cardiovascular Agents
Calcium Channel Blockers
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 19, 2013