NCT01175746

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

August 2, 2010

Last Update Submit

June 11, 2013

Conditions

Keywords

healthy adult patientsASA class Ihypotensive anesthesia

Outcome Measures

Primary Outcomes (1)

  • Creatinine Clearance

    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

Study Arms (2)

nicardipine

EXPERIMENTAL
Drug: Nicardipine

remifentanil

ACTIVE COMPARATOR
Drug: remifentanil

Interventions

nicardipine

0.1-0.5 ugkg/min during hypotensive anesthesia

Also known as: ultiva®
remifentanil

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adult patients undergoing hypotensive anesthesia

You may not qualify if:

  • patients with any co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

NicardipineRemifentanil

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidines

Study Officials

  • Ji Young Kim

    Severance hospital, YUHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 5, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

June 13, 2013

Record last verified: 2013-06