The Pharmacokinetics of Opioids and Sedative/Hypnotics During Selective Cerebral Perfusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ervant V. Nishanian, Columbia University
ClinicalTrials.gov Identifier:
NCT00494598
First received: June 28, 2007
Last updated: July 31, 2013
Last verified: October 2008
  Purpose

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 Intervention Phase
Aortic Aneurysm
Drug: Sufentanil
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pharmacokinetics of Opioids and Sedative/Hypnotics During Selective Cerebral Perfusion

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Pharmacokinetics of intra-carotid opioids and sedatives during selective cerebral perfusion [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 6
Study Start Date: March 2007
Study Completion Date: June 2007
Intervention Details:
    Drug: Sufentanil
    200 mcg intra-arterial one time bolus
    Other Name: sufenta
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all patients undergoing aortic arch surgery

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00494598

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

No publications provided

Responsible Party: Ervant V. Nishanian, Asst Professor of Clinical, Department of Anethesiology Clinical Operations, Columbia University
ClinicalTrials.gov Identifier: NCT00494598     History of Changes
Other Study ID Numbers: AAAC2983
Study First Received: June 28, 2007
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
opioids, cerebral perfusion, arterial pharmacokinetics

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Hypnotics and Sedatives
Sufentanil
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 24, 2014