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

• ClinicalTrials.gov Identifier: NCT01175746
• Recruitment Status: Completed
• First Posted: August 5, 2010
• Last Update Posted: June 13, 2013
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: August 2, 2010
• First Posted Date: August 5, 2010
• Last Update Posted Date: June 13, 2013
• Study Start Date: August 2010
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 4, 2010)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Nicardipine on Kidney Function During Orthognathic Surgery Under Hypotensive Anesthesia
• Official Title: Not Provided
• Brief Summary: Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Healthy Subjects

Intervention

• Drug: Nicardipine
• Drug: remifentanil
  0.1-0.5 ugkg/min during hypotensive anesthesia
  Other Name: ultiva®

Study Arms

• Experimental: nicardipine
  Intervention: Drug: Nicardipine
• Active Comparator: remifentanil
  Intervention: Drug: remifentanil

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 4, 2010): 46
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• healthy adult patients undergoing hypotensive anesthesia

Exclusion Criteria:

• patients with any co-morbidity

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01175746
• Other Study ID Numbers: 3-2009-0196
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Yonsei University
• Original Responsible Party: Ji Young Kim/assistant professor, Severance Hospital, YUHS
• Current Study Sponsor: Yonsei University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ji Young Kim; Severance hospital, YUHS

• PRS Account: Yonsei University
• Verification Date: June 2013