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A Prospective, Randomized, Double-Blind, Placebo-Controlled Pilot Study of Single-Dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients

Cancer Type
Head and Neck Cancer
Oral Cancer
Trial Phase
18 and over, Male and Female
Study Type
Supportive care
Protocol IDs
EU3268-16 (primary)
Study Sponsor
Emory University/Winship Cancer Institute


This pilot clinical trial studies how well ketamine works in preventing delirium in patients with head and neck cancer after surgery. Ketamine may reduce the amount of pain after surgery and the incidence of confused state.



I. Optimize our intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction.


I. Determine the dose response relationship for intraoperative ketamine and delirium reduction.

II. Determine if a single dose of ketamine will reduce post-operative pain and opioid requirements.

III. Determine if raw EEG data can predict postoperative delirium during general anesthesia.

IV. Evaluate length of ICU and length of hospital stay (done by medical chart review).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive lower dose ketamine intravenously (IV) before surgery.

ARM II: Patients receive higher dose ketamine IV before surgery.

ARM III: Patients receive placebo IV before surgery.

After completion of study treatment, patients are followed up 2-6 weeks post-surgery.

Treatment Sites in Georgia

Emory University Hospital - Midtown

550 Peachtree Street NE
Atlanta, GA 30308

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