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

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ClinicalTrials.gov Identifier: NCT03040024
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Vanessa Moll, 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.

Condition or disease Intervention/treatment Phase
Otolaryngeal Cancer Drug: Ketamine Drug: Placebo Device: Electroencephalogram (EEG) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Ketamine

Arm Intervention/treatment
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.
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.
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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".


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. Post Operative Narcotics Use [ Time Frame: Post Intervention (Up to Day 3) ]
    The total amount of narcotics used measured in milligrams.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Contacts
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Contact: Vanessa Moll, PhD 404-686-2747: vanessa.moll@emory.edu

Locations
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United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Vanessa Moll, PhD    404-686-2747    vanessa.moll@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Vanessa Moll, PhD Emory University

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Responsible Party: Vanessa Moll, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03040024     History of Changes
Other Study ID Numbers: IRB00086609
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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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

Keywords provided by Vanessa Moll, Emory University:
Anesthesiology

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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