The Effects of DexMed and Desflurane on Carotid Patients

Condition(s) targeted: Carotid Artery Stenosis

Intervention: Remifentanil (Drug); Dexmedetomidine (Drug); Remifentanil and Desflurane (Drug); Desflurane (Drug); Dexmedetomidine and Desflurane (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Outcomes Research Consortium

Official(s) and/or principal investigator(s):
Ehab Farag, MD, Principal Investigator, Affiliation: Cleveland Clinic

We propose to test whether intraoperative administration of dexmedetomidine will reduce postoperative neurocognitive dysfunction in patients undergoing carotid endarterectomy.

Official title: Phase 4: The Effects of Dexmedetomidine and Desflurane on Postoperative Cognitive Dysfunction in Patients Undergoing Carotid Endarterectomy

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Factorial Assignment, Efficacy Study

Primary outcome: Neurocognition

Detailed description: Stroke is the third leading cause of death and the leading cause of severe long-term disability with serious physical and psychosocial effects. Each year about 700,000 people experience a new or recurrent stroke out of which 88% are ischemic. Atherosclerotic carotid artery disease is a major contributor to the incidence of stroke, particularly in the elderly. Carotid endarterectomy (CEA) is believed to reduce the risk of stroke in patients with symptomatic as well as non-symptomatic carotid artery stenosis and is the most frequently performed surgical procedure to prevent stroke.

However, CEA itself carries a risk of complications. Although the incidence of overt neurological injury associated with CEA is low, cognitive injuries not revealed in routine neurological examinations are believed to be as high as 20-30%.

The purpose of this study is to determine the neuro-protective (brain-protecting) effect of the Food and Drug Administration (FDA) approved drug, dexmedetomidine and desflurane in patients undergoing a carotid endarterectomy surgery. We will also determine if administering anesthetics by intravenous route (through blood) is brain-protecting as compared to inhaled anesthetics administered. It is expected that the action of these techniques on brain will decrease the neurological (brain) damage after a period of decreased blood supply to the brain that normally occurs during the procedure. This neuroprotective action has already been demonstrated in animal studies.

The goals for intraoperative anesthetic management of CEA include protection of the brain from ischemic injury. Dexmedetomidine has been found to be neuroprotective in vivo and vitro models of hypoxic-ischemic injury. We therefore propose to test whether intraoperative administration of dexmedetomidine will reduce postoperative neurocognitive dysfunction in patients undergoing CEA.

Desflurane has been shown to be neuroprotective after incomplete cerebral ischemia. Desflurane not only attenuates the decrease but also increases brain tissue oxygenation and pH during ischemic injury and might improve neurological outcome. Neurocognitive outcomes may thus be superior with desflurane than with total intravenous anesthesia (TIVA). We thus also propose to test whether desflurane anesthesia reduces the incidence of postoperative neurocognitive dysfunction in patients undergoing carotid endarterectomy (CEA).

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Consenting adult patients (age >50 years) undergoing carotid endarterectomy with

general anesthesia.

Exclusion Criteria:

- Receiving another alpha 2-adrenoreceptor agonist;

- Contraindication to dexmedetomidine, including allergy;

- Current hepatic disease (liver function tests > twice upper limit of normal);

- Renal insufficiency, as defined by a creatinine > 2. 0 mg/dL;

- Mentally impairment, including dementia or delirium;

- Heart block ;

- Sick sinus syndrome;

- Atrial fibrillation with a low ventricular response (< 50 bpm);

- Absolute or relative hypovolemia;

- Prior stroke;

- Severe left-ventricular dysfunction

Cleveland Clinic, Cleveland, Ohio 44195, United States

Starting date: June 2006
Ending date: June 2008
Last updated: May 22, 2008