Clinical trial NCT03040024: Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
Official title: A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Otolaryngeal Cancer
Keywords: Anesthesiology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
timeFrame: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)
Secondary outcomes:
measure: Change in Behavioral Pain Scale (Non-Intubated) Score
timeFrame: Post Operation (Up to 6 Hours), Post Operation Day 0
measure: Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score
timeFrame: Baseline, Post Surgery (PACU), Post surgery (POD 0), Post surgery (POD 1), Post surgery (POD 2), Post surgery (POD 3), Post surgery (follow up visit - Up to 6 weeks)
measure: Change in Mini Cog Score
timeFrame: Baseline, Post Surgery (Up to 6 Weeks)
measure: Change in Mini-Mental Status Examination (MMSE) Score
timeFrame: Baseline, Post Surgery (Up to 6 Weeks)
measure: Change in Cognitive Failure Questionnaire (CFQ) Score
timeFrame: Baseline, Post Surgery (Up to 6 Weeks)
measure: Post Operative Narcotics Use
timeFrame: Post Intervention (Intraoperative), Post Intervention (POD 0), Post Intervention (POD 1),Post Intervention (POD 2),Post Intervention (POD 3), Post Intervention (Follow up visit-up to 6 weeks post intervention)
measure: Associations of Intraoperative EEG Patterns With PACU Delirium
timeFrame: Intraoperative EEG and delirium during PACU stay
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Vanessa Moll, PhD
role: PRINCIPAL_INVESTIGATOR
References: