Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
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ClinicalTrials.gov Identifier: NCT03040024 |
Recruitment Status :
Terminated
(Halted due to COVID 19; we believe we have adequate data for analysis)
First Posted : February 1, 2017
Last Update Posted : May 14, 2020
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Condition or disease | Intervention/treatment | Phase |
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Otolaryngeal Cancer | Drug: Ketamine Drug: Placebo Device: Electroencephalogram (EEG) | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Other |
Official Title: | A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients |
Actual Study Start Date : | March 17, 2017 |
Actual Primary Completion Date : | February 24, 2020 |
Actual Study Completion Date : | April 24, 2020 |

Arm | Intervention/treatment |
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Experimental: Ketamine 0.5 mg/kg
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg.
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Drug: Ketamine
Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Device: Electroencephalogram (EEG) A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
Experimental: Ketamine 1.0 mg/kg
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
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Drug: Ketamine
Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision. Device: Electroencephalogram (EEG) A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
Placebo Comparator: Placebo
Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.
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Drug: Placebo
Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Other Name: Saline Solution Device: Electroencephalogram (EEG) A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium. |
- Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score [ Time Frame: Baseline, Post Operative Day 3 ]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 = deliriuim positive.
- Richmond Agitation and Sedation (RASS) Score [ Time Frame: Post Operation (Up to 6 Hours) ]The RASS is a medical scale used to measure the agitation or sedation level of a patient. Scores range from -5 to +4; -5 representing "unarousable" and +4 representing "combative".
- Change in Behavioral Pain Scale (Non-Intubated) Score [ Time Frame: Post Operation (Up to 4 Hours), Post Operation Day 3 ]The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).
- Change in Pain Level assessed by the Visual Analog Scale (VAS) Score [ Time Frame: Baseline, Post Surgery (Up to 6 Weeks) ]Scores range from 0 (no pain) to 10 (worst pain).
- Change in Mini Cog Score [ Time Frame: 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.
- Change in Mini-Mental Status Examination (MMSE) Score [ Time Frame: 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, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
- Change in Cognitive Failure Questionnaire (CFQ) Score [ Time Frame: 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 [ Time Frame: Post Intervention (Up to Day 3) ]The total amount of narcotics used measured in milligrams.
- Average Length of Intensive Care Unit (ICU) Stay [ Time Frame: Duration of Study (Up to Six Weeks) ]The average length of time spent in the ICU measured in hours.
- Average Length of Hospital Stay [ Time Frame: Duration of Study (Up to Six Weeks) ]The average length of time spent in the hospital measured in days.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040024
United States, Georgia | |
Emory University Hospital Midtown | |
Atlanta, Georgia, United States, 30308 |
Principal Investigator: | Vanessa Moll, PhD | Emory University |
Responsible Party: | Amit Prabhakar, Assistant Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT03040024 |
Other Study ID Numbers: |
IRB00086609 |
First Posted: | February 1, 2017 Key Record Dates |
Last Update Posted: | May 14, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Anesthesiology |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |