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

Phase 4

Terminated

• Conditions: Otolaryngeal Cancer
• Interventions: Drug: Placebo; Drug: Ketamine; Device: Electroencephalogram (EEG)

• Registration Number: NCT03040024
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Study Start: 2017-03-17
• Primary Completion: 2020-02-24
• Study Completion: 2020-04-24
• Results First Submitted: 2021-02-24
• Results First Submitted QC: 2021-02-24
• Results First Posted: 2021-03-19
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Current diagnosis of otolaryngeal cancer and undergoing surgery with general anesthesia
• Competent to provide informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketamine 0.5 mg/kg	Electroencephalogram (EEG)	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
Placebo	Placebo	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
Ketamine 1.0 mg/kg	Electroencephalogram (EEG)	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
Placebo	Electroencephalogram (EEG)	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
Ketamine 0.5 mg/kg	Ketamine	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
Ketamine 1.0 mg/kg	Ketamine	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.

Primary Outcome Measures

Name	Time	Method
Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score	Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)	The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.

Secondary Outcome Measures

Name	Time	Method
Change in Behavioral Pain Scale (Non-Intubated) Score	Post Operation (Up to 6 Hours), Post Operation Day 0	The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).
Change in Cognitive Failure Questionnaire (CFQ) Score	Baseline, Post Surgery (Up to 6 Weeks)	The CFQ is a 25-item self-report measure of failures in attention, perception, memory, and action. Participants are asked to indicate on a 5-point scale how often they have experienced each failure in the past months, from 0 (never) to 5 (very often). Scores range from 0 to 100 a higher score indicating more failures in attention.
Post Operative Narcotics Use	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)	The total amount of narcotics used measured in morphine milligram equivalents (MME).
Change in Mini-Mental Status Examination (MMSE) Score	Baseline, Post Surgery (Up to 6 Weeks)	The MMSE is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this (0-24), scores can indicate cognitive impairment.
Associations of Intraoperative EEG Patterns With PACU Delirium	Intraoperative EEG and delirium during PACU stay	The investigators compared the relative beta power derived from the normalized power spectral density (PSD) in patients with and without PACU delirium (positive and negative delirium). Only a total of 38 EEGs with sufficient quality were analyzed. Results are expressed in percentage of cumulative power. A higher beta power correlates with worse outcome. Averages and standard deviations are shown.
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score	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)	Scores range from 0 (no pain) to 10 (worst pain).
Change in Mini Cog Score	Baseline, Post Surgery (Up to 6 Weeks)	The Mini-Cog is a 3-minute instrument that can increase detection of cognitive impairment. A score ranging from 0-2 indicates positive screen for dementia. A score ranging from 3-5 indicates negative screen for dementia.

Trial Locations

Locations (1)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States