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

NCT03040024 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00086609
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Otolaryngeal Cancer

Keywords

Anesthesiology

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Post Operation (Up to 6 Hours), Post Operation Day 0

• Change in Pain Level Assessed by the Visual Analog Scale (VAS) Score

  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

  Baseline, Post Surgery (Up to 6 Weeks)

• Change in Mini-Mental Status Examination (MMSE) Score

  Baseline, Post Surgery (Up to 6 Weeks)

• Change in Cognitive Failure Questionnaire (CFQ) Score

  Baseline, Post Surgery (Up to 6 Weeks)

Study Arms (3)

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.

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.

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.

Drug: Placebo; Device: Electroencephalogram (EEG)

Interventions

Ketamine DRUG

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

Ketamine 0.5 mg/kg; Ketamine 1.0 mg/kg

Placebo DRUG

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

Also known as: Saline Solution

Placebo

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.

Ketamine 0.5 mg/kg; Ketamine 1.0 mg/kg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Interventions

Ketamine; Saline Solution; Electroencephalography

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Results Point of Contact

• Title: Dr. Amit Prabhakar
• Organization: Emory University

amit.prabhakar@emory.edu

404-686-2747

Study Officials

• Vanessa Moll, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 1, 2017
• Study Start: March 17, 2017
• Primary Completion: February 24, 2020
• Study Completion: April 24, 2020
• Last Updated: July 8, 2021
• Results First Posted: March 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)