NCT02001298

Brief Summary

The purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
Last Updated

December 4, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

November 24, 2013

Last Update Submit

December 3, 2013

Conditions

Keywords

remifentanilnitroprussidehypotension

Outcome Measures

Primary Outcomes (1)

  • Cardiac index

    Cardiac index was continuously measured during controlled hypotension using noninvasive cardiac output monitor. The average of cardiac index during controlled hypotension was compared with baseline value.

    Cardiac index was continuously measured during controlled hypotension, an average of 90 min

Secondary Outcomes (1)

  • Total peripheral resistance index

    Total peripheral resistance index was continuously measured during controlled hypotension, an average of 90 min

Other Outcomes (1)

  • Stroke volume index

    Stroke volume index was continuously measured during controlled hypotension, an average of 90 min

Study Arms (2)

nitroprusside

EXPERIMENTAL

After induction of anesthesia, controlled hypotension was induced with continuous infusion of nitroprusside. Cardiac index, stroke volume index, and total peripheral resistance index were continuously measured using noninvasive cardiac output monitor (Cheetah NICOM, Cheetah Medical Inc, UK).

Drug: nitroprusside

remifentanil

EXPERIMENTAL

After induction of anesthesia, controlled hypotension was induced with continuous infusion of remifentanil. Cardiac index, stroke volume index, and total peripheral resistance index were continuously measured using noninvasive cardiac output monitor (Cheetah NICOM, Cheetah Medical Inc, UK).

Drug: remifentanil

Interventions

remifentanil
nitroprusside

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who underwent endoscopic sinus surgery

You may not qualify if:

  • patient who took any drug to influence this study
  • patient with cardiovascular disease, renal disease or liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeju National University Hospital

Jeju City, Jeju Special Self-Governing Province, 690-767, South Korea

Location

MeSH Terms

Conditions

Hypotension

Interventions

RemifentanilNitroprusside

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFerricyanidesCyanidesAnionsIonsElectrolytesInorganic ChemicalsFerric CompoundsIron CompoundsHydrogen CyanideNitrogen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 24, 2013

First Posted

December 4, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-11

Locations