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

NCT03040024 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-07-08

Study results available
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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.

Conditions

  • Otolaryngeal Cancer

Interventions

DRUG

Ketamine

Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.

DRUG

Placebo

Placebo 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.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Vanessa Moll, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-17
Primary Completion
2020-02-24
Completion
2020-04-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03040024 on ClinicalTrials.gov