TerminatedPhase 4

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

Stopped: Halted due to COVID 19; we believe we have adequate data for analysis

United States71 participantsStarted 2017-03-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT03040024

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-24

Results submitted2021-02-24

View on ClinicalTrials.gov More Otolaryngeal Cancer trials