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

June 11, 2013 updated by: Yonsei University
Since nicardipine is known to protect kidney function, nicardipine infusion will result in better renal parameters measured in this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

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 to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adult patients undergoing hypotensive anesthesia

Exclusion Criteria:

  • patients with any co-morbidity

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: remifentanil
Drug: remifentanil
0.1-0.5 ugkg/min during hypotensive anesthesia
Other Names:
  • ultiva®
Experimental: nicardipine
Drug: Nicardipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2hr after the start of hypotensive anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Ji Young Kim, Severance Hospital, YUHS

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

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (Estimate)

August 5, 2010

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2009-0196

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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