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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

Status
Active
Cancer Type
Head and Neck Cancer
Oral Cancer
Trial Phase
Eligibility
18 and over, Male and Female
Study Type
Supportive care
NCD ID
NCT03040024
Protocol IDs
EU3268-16 (primary)
NCI-2017-00172
IRB00086609
Study Sponsor
Emory University/Winship Cancer Institute

Summary

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.

Objectives

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 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
404-686-4411
www.emoryhealthcare.org

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