Remifentanil and Nitroprusside for Controlled Hypotension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyun Jung Kim, Jeju National University School of Medicine
ClinicalTrials.gov Identifier:
NCT02001298
First received: November 24, 2013
Last updated: December 3, 2013
Last verified: November 2013
  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: 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 24, 2013
Last Updated: December 3, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Jeju National University School of Medicine:
remifentanil
nitroprusside
hypotension

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

ClinicalTrials.gov processed this record on July 24, 2014