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Trial record 1 of 2 for:    "Aortic Aneurysm" | "Sufentanil"
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The Pharmacokinetics of Opioids and Sedative/Hypnotics During Selective Cerebral Perfusion

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. Identifier: NCT00494598
Recruitment Status : Completed
First Posted : July 2, 2007
Last Update Posted : August 1, 2013
Information provided by (Responsible Party):
Ervant V. Nishanian, Columbia University

Brief Summary:
There is a need to understand how long anesthetic drugs last in the brain during surgery on the ascending aorta or aortic arch. Drugs can have a prolonged effect when blood temperature is made cold therefore the influence of temperature needs to be studied. This type of surgery allows us to answer questions about how anesthetic drugs behave when they are given during a routine portion of surgery. Patients will be provided with anesthetic drugs during surgery while on a heart lung machine. After the drug is injected into the heart lung machine it will be delivered to the brain to provide more sleep and pain relief. Immediately after the injection of anesthetic drugs, blood samples will be taken from an existing intravenous line in the neck and plasma drug concentrations measured. This will help us to understand how long drugs last in the brain during this type of surgery.

Condition or disease Intervention/treatment
Aortic Aneurysm Drug: Sufentanil

Detailed Description:

The purpose of this study is to understand the disposition of sufentanil, midazolam and morphine when the drugs are introduced into the arterial circulation of the brain. Patients undergoing surgery on the ascending aorta or aortic arch often require cessation of blood flow to the organs of the body, while maintaining some degree of blood flow to the brain. In order to achieve organ protection during the circulatory arrest phase of surgery, the body is cooled to a core temperature of 28°C. Various techniques including deep hypothermic circulatory arrest, retrograde cerebral perfusion through the superior vena cava, and partial or bilateral antegrade selective cerebral perfusion have been proposed as means to protect the brain from ischemic injury during surgery on the aortic arch. At our institution selective cerebral perfusion has found success for major aortic surgery. This technique was devised and first employed by DeBakey and associates, to protect the brain during aortic arch surgery with bilateral carotid perfusion [1]. Selective cerebral perfusion requires the surgical construction and placement of a Dacron graft onto the right axillary artery that when connected to a cardiopulmonary bypass machine it will provide 10 ml/kg/min antegrade flow for brain perfusion [2]. Cerebral cooling will also decrease the oxygen demand of the brain. In such a way brain ischemia may be minimized. The nature of major aortic arch surgery requires independent cerebral circulation or selective cerebral perfusion for a finite period of time. The cardiopulmonary bypass machine is allowed to perfuse the brain indirectly by serial flow through the right axillary artery to the innominate artery and finally to the right carotid artery. Any anesthetic drug that is introduced into the cardiopulmonary bypass circuit will be delivered the same way. We will take advantage of this independent circuit to safely deliver anesthetic drugs to the brain via the right carotid artery during surgery.

A prior study that enrolled 6 patients has shown that the anesthetic administration is safe and feasible. Patients had no problems related to anesthesia or surgery. All patients left the hospital in stable condition.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacokinetics of Opioids and Sedative/Hypnotics During Selective Cerebral Perfusion
Study Start Date : March 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Sufentanil
    200 mcg intra-arterial one time bolus
    Other Name: sufenta

Primary Outcome Measures :
  1. Pharmacokinetics of intra-carotid opioids and sedatives during selective cerebral perfusion [ Time Frame: one week ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients undergoing aortic arch surgery

Inclusion Criteria:

  • The study population will comprise individuals who have elected to undergo aortic arch surgery or re-operative cardiac surgery requiring selective cerebral perfusion.
  • Patients will be treated according to the standard medical practice of Columbia University Medical Center.
  • Patients will be within 21 to 90 years of age.

Exclusion Criteria:

  • Patients having known hypersensitivity to the anesthetic agents being studied will be excluded.

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 identifier (NCT number): NCT00494598

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United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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Principal Investigator: Ervant Nishanian, PhD MD Columbia University

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Responsible Party: Ervant V. Nishanian, Asst Professor of Clinical, Department of Anethesiology Clinical Operations, Columbia University Identifier: NCT00494598     History of Changes
Other Study ID Numbers: AAAC2983
First Posted: July 2, 2007    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: October 2008
Keywords provided by Ervant V. Nishanian, Columbia University:
opioids, cerebral perfusion, arterial pharmacokinetics
Additional relevant MeSH terms:
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Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Analgesics, Opioid
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General