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 range18 Years

SexALL

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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

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