- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001298
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
Conditions
Intervention / Treatment
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
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Nitric Oxide Donors
- Remifentanil
- Nitroprusside
Other Study ID Numbers
- HJKim3
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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