Remifentanil and Nitroprusside for Controlled Hypotension

December 3, 2013 updated by: Hyun Jung Kim, Jeju National University School of Medicine

The Comparison of the Cardiovascular Effects of Remifentanil and Nitroprusside for Controlled Hypotension

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

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jeju Special Self-Governing Province
      • Jeju-si, Jeju Special Self-Governing Province, Korea, Republic of, 690-767
        • Jeju National University Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent endoscopic sinus surgery

Exclusion Criteria:

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

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nitroprusside
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).
Experimental: remifentanil
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac index
Time Frame: Cardiac index was continuously measured during controlled hypotension, an average of 90 min
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total peripheral resistance index
Time Frame: Total peripheral resistance index was continuously measured during controlled hypotension, an average of 90 min
Total peripheral resistance index was continuously measured during controlled hypotension using noninvasive cardiac output monitor. The average of total peripheral resistance index during controlled hypotension was compared with baseline value.
Total peripheral resistance index was continuously measured during controlled hypotension, an average of 90 min

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke volume index
Time Frame: Stroke volume index was continuously measured during controlled hypotension, an average of 90 min
Stroke volume index was continuously measured during controlled hypotension using noninvasive cardiac output monitor. The average of stroke volume index during controlled hypotension was compared with baseline value.
Stroke volume index was continuously measured during controlled hypotension, an average of 90 min

Collaborators and Investigators

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

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

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 24, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

November 1, 2013

More Information

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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