This pilot phase IV 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03040024.
PRIMARY OBJECTIVES:
I. Optimize our intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction.
SECONDARY OBJECTIVES:
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 electroencephalography (EEG) data can predict postoperative delirium during general anesthesia.
IV. Evaluate length of intensive care unit (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.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorAmit Prabhakar
