The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia
This study has been completed.
Information provided by (Responsible Party):
First received: August 2, 2010
Last updated: June 11, 2013
Last verified: June 2013
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2011 (Final data collection date for primary outcome measure)
Active Comparator: remifentanil
0.1-0.5 ugkg/min during hypotensive anesthesia
Other Name: ultiva®
|Ages Eligible for Study:
||20 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- healthy adult patients undergoing hypotensive anesthesia
- patients with any co-morbidity
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175746
||Ji Young Kim
||Severance hospital, YUHS
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2010
||June 11, 2013
||South Korea: Korea Food and Drug Administration (KFDA)
Keywords provided by Yonsei University:
healthy adult patients
ASA class I
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 01, 2016
Calcium Channel Blockers
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents