Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:March 17, 2017
End Date:September 2020
Contact:Vanessa Moll, PhD
Email:vanessa.moll@emory.edu
Phone:404-686-2747:

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A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients

The goal of this prospective randomized double blinded placebo controlled study is to
investigate if a single dose of ketamine in addition to standard anesthesia will reduce the
risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on
post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will
be utilized during the surgical procedure to evaluate its potential as a possible predictive
device for delirium.

This is a single center prospective randomized double blinded placebo controlled study.

The primary aim of the study is to optimize the intraoperative treatment protocol for head
and neck cancer patients to reduce the incidence of delirium and associated postoperative
cognitive dysfunction. Secondary aims are to determine the dose response relationship for
intraoperative ketamine and delirium reduction, determine if a single dose of ketamine will
reduce post-operative pain and opioid requirements, determine if raw electroencephalogram
(EEG) data can predict postoperative delirium during general anesthesia, and to evaluate
length of intensive care unit (ICU) and length of hospital stay.

Participants will be randomized to one of three groups after administration of general
anesthesia; one dose of .5 mg/kg intravenous (IV) Ketamine, 1.0 mg/kg of IV Ketamine, or IV
placebo.

An EEG will be used during the surgical procedure to gather raw data for off line analysis
among patients developing post-operative delirium.

Inclusion Criteria:

- Current diagnosis of otolaryngeal cancer and undergoing surgery with general
anesthesia

- Competent to provide informed consent

Exclusion Criteria:

- Emergency surgery

- Monitored Anesthesia Care (i.e., regional anesthesia alone without plans for general
anesthesia)

- Surgery involving the eye, eyebrow, forehead, or frontal scalp near the sensor
placement

- Poor health literacy

- Allergy, or have experienced any drug reaction to ketamine

- Pregnant or lactating

- Currently in active alcohol withdrawal

- Taking buprenorphine for chronic pain
We found this trial at
1
site
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Phone: 404-686-2747
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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