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

NCT ID: NCT03040024

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-17
• Study Completion Date: 2020-04-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Electroencephalogram (EEG)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Electroencephalogram (EEG)

Intervention Type: 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.

Placebo

Participants undergoing surgery for otolaryngeal cancer will be randomized to receive one dose of IV saline/placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Electroencephalogram (EEG)

Intervention Type: 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.

Interventions

Ketamine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

Saline Solution

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Amit Prabhakar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vanessa Moll, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00086609

Identifier Type: -

Identifier Source: org_study_id