Otolaryngeal CancerPhase 4NCT03040024

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

A Phase 4 study testing Ketamine and Electroencephalogram (EEG) in people with Otolaryngeal Cancer, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Otolaryngeal Cancer
What is being tested?: Ketamine and Electroencephalogram (EEG)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 1 siteUnited States
Study dates: 17 Mar 2017to 24 Apr 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital Midtown
Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients

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.

Read the 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.

Conditions: Otolaryngeal Cancer
Being tested: Ketamine, Placebo, Electroencephalogram (EEG)
Keywords: Anesthesiology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KetamineDrug
Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
PlaceboDrug
Also called Saline Solution
Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
Electroencephalogram (EEG)Device
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.

Study groups in NCT03040024
Study group	Role	What they receive
Ketamine 0.5 mg/kg	Experimental	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 0.5 mg/kg. Receives: Drug: Ketamine; Device: Electroencephalogram (EEG)
Ketamine 1.0 mg/kg	Experimental	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg. Receives: Drug: Ketamine; Device: Electroencephalogram (EEG)
Placebo	Placebo comparator	Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo. Receives: Drug: Placebo; Device: Electroencephalogram (EEG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
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.
Measured: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)

Secondary outcomes (7)

Change in Behavioral Pain Scale (Non-Intubated) Score
The Behavioral Pain Scale. Scores range from 3 (no pain) to 12 (maximum pain).
Measured: Post Operation (Up to 6 Hours), Post Operation Day 0
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score
Scores range from 0 (no pain) to 10 (worst pain).
Measured: 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)
Change in Mini Cog Score
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.
Measured: Baseline, Post Surgery (Up to 6 Weeks)
Change in Mini-Mental Status Examination (MMSE) Score
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.
Measured: Baseline, Post Surgery (Up to 6 Weeks)
Change in Cognitive Failure Questionnaire (CFQ) Score
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.
Measured: Baseline, Post Surgery (Up to 6 Weeks)
Post Operative Narcotics Use
The total amount of narcotics used measured in morphine milligram equivalents (MME).
Measured: 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)
Associations of Intraoperative EEG Patterns With PACU Delirium
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.
Measured: Intraoperative EEG and delirium during PACU stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Mar 201724 Apr 2020

First posted1 Feb 2017 (estimated)
Study start17 Mar 2017
Primary completion24 Feb 2020
Study completion24 Apr 2020

Why it stopped: Halted due to COVID 19; we believe we have adequate data for analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Otolaryngeal CancerStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03040024
Sponsor's protocol ID: IRB00086609
Status last verified: Jul 2021
First submitted: 31 Jan 2017
Last updated: 8 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Placebo-controlled Pilot Study of Single-dose Intraoperative Ketamine for the Prevention of Delirium in Otolaryngeal Cancer Surgery Patients
ClinicalTrials.gov ID: NCT03040024
Acronym / sponsor ID: IRB00086609
Conditions: Otolaryngeal Cancer
Keywords: Anesthesiology
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Halted due to COVID 19; we believe we have adequate data for analysis
Enrolment: 71 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 17 Mar 2017 (actual)
Primary completion: 24 Feb 2020 (actual)
Study completion: 24 Apr 2020 (actual)
First posted: 1 Feb 2017 (estimated)
Results: Posted 19 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a single center prospective randomized double blinded placebo controlled study.

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 design

Primary purpose: Other
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Ketamine 0.5 mg/kg	Experimental	Drug: Ketamine, Device: Electroencephalogram (EEG)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	Experimental	Drug: Ketamine, Device: Electroencephalogram (EEG)Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV ketamine at 1.0 mg/kg.
Placebo	Placebo comparator	Drug: Placebo, Device: Electroencephalogram (EEG)Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KetamineKetamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.	Drug	Ketamine 0.5 mg/kg, Ketamine 1.0 mg/kg
PlaceboAlso: Saline SolutionPlacebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.	Drug	Placebo
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.	Device	Ketamine 0.5 mg/kg, Ketamine 1.0 mg/kg, Placebo

Primary outcome

Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score
Time frame: 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.

7 secondary outcomes

Change in Behavioral Pain Scale (Non-Intubated) Score
Time frame: Post Operation (Up to 6 Hours), Post Operation Day 0
Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score
Time frame: 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)
Change in Mini Cog Score
Time frame: Baseline, Post Surgery (Up to 6 Weeks)
Change in Mini-Mental Status Examination (MMSE) Score
Time frame: Baseline, Post Surgery (Up to 6 Weeks)
Change in Cognitive Failure Questionnaire (CFQ) Score
Time frame: Baseline, Post Surgery (Up to 6 Weeks)
Post Operative Narcotics Use
Time frame: 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)
Associations of Intraoperative EEG Patterns With PACU Delirium
Time frame: Intraoperative EEG and delirium during PACU stay

Results and safety

Results posted to the registry on 19 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketamine 0.5 mg/kg	21	21
Ketamine 1.0 mg/kg	26	24
Placebo	24	23

Primary outcome: Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score

Time frame: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours). Count of participants. Unit: Participants

Measure	Ketamine 0.5 mg/kg n = 17	Ketamine 1.0 mg/kg n = 22	Placebo n = 17
Delirium CAM-ICU Score at PACU Arrival	11	9	9
No Delirium CAM-ICU Score at PACU Arrival	6	13	10
Delirium CAM-ICU Score at PACU Discharge	6	5	2
No Delirium CAM-ICU Score at PACU Discharge	11	17	15

Population analysed: Unable to collect data in 15 participants. N=12: Provider not available. N=2 No PACU. N=1 Physician Decision (withdrawal)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: The research team monitored subjects randomized and treated in the study for adverse events related to the research through the final study visit in the ENT clinic that occurred from 2 to 6 weeks post-operatively.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketamine 0.5 mg/kg	4 of 21 (19%)	3 of 21 (14.3%)	0 of 21
Ketamine 1.0 mg/kg	9 of 26 (34.6%)	5 of 26 (19.2%)	1 of 26
Placebo	2 of 24 (8.3%)	4 of 24 (16.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vanessa Moll, PhD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine and Electroencephalogram (EEG) in people with Otolaryngeal Cancer, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Confusion Assessment Method fo Intensive Care Unit (CAM-ICU) Delirium Score (time frame: Baseline (Up to 30 minutes after PACU arrival), Post Operative (PACU discharge up to 6 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03040024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.