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

Emory University

Status and phase: Terminated; Phase 4

Conditions: Otolaryngeal Cancer

Treatments: Drug: Placebo; Drug: Ketamine; Device: Electroencephalogram (EEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03040024

IRB00086609

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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71 participants in 3 patient groups, including a placebo group

Ketamine 0.5 mg/kg

Experimental group

Description:

Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.

Treatment:

Drug: Ketamine

Device: Electroencephalogram (EEG)

Ketamine 1.0 mg/kg

Experimental group

Description:

Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.

Treatment:

Drug: Ketamine

Device: Electroencephalogram (EEG)

Placebo

Placebo Comparator group

Description:

Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.

Treatment:

Drug: Placebo

Device: Electroencephalogram (EEG)