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Remifentanil and Nitroprusside for Controlled Hypotension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02001298
First Posted: December 4, 2013
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyun Jung Kim, Jeju National University School of Medicine
  Purpose
The purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension

Condition Intervention
Hypotension, Controlled Drug: remifentanil Drug: nitroprusside

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Comparison of the Cardiovascular Effects of Remifentanil and Nitroprusside for Controlled Hypotension

Resource links provided by NLM:


Further study details as provided by Hyun Jung Kim, Jeju National University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: June 2012
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: nitroprusside
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).
Drug: remifentanil

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001298


Locations
Korea, Republic of
Jeju National University Hospital
Jeju-si, Jeju Special Self-Governing Province, Korea, Republic of, 690-767
Sponsors and Collaborators
Jeju National University School of Medicine
  More Information

Responsible Party: Hyun Jung Kim, Assistant professor, Jeju National University School of Medicine
ClinicalTrials.gov Identifier: NCT02001298     History of Changes
Other Study ID Numbers: HJKim3
First Submitted: November 24, 2013
First Posted: December 4, 2013
Last Update Posted: October 12, 2017
Last Verified: November 2013

Keywords provided by Hyun Jung Kim, Jeju National University School of Medicine:
remifentanil
nitroprusside
hypotension

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Remifentanil
Nitroprusside
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action