Ketamine in Preventing Delirium in Patients with Head and Neck Cancer after Surgery

Status: Active

Description

This pilot phase IV trial studies how well ketamine works in preventing delirium in patients with head and neck cancer after surgery. Ketamine may reduce the amount of pain after surgery and the incidence of confused state.

Eligibility Criteria

Inclusion Criteria

  • With otolaryngeal cancer receiving surgery with general anesthesia * Please note we are purposefully including patients with higher predisposition to delirium as we are investigating potential preventive strategies for this diagnosis of multiple etiologies; patients at higher risk of delirium (e.g., advanced age, chronic hypertension) will be included in our study; additionally, other common risk factors that exist in this patient population (e.g., alcohol or nicotine use) are thought to contribute to delirium postoperatively
  • 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
  • Patients with an allergy, or have experienced any drug reaction to ketamine will be excluded
  • Pregnant or lactating patients
  • Patients in active alcohol withdrawal
  • Patients with chronic pain who are taking buprenorphine

Locations & Contacts

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Vanessa Moll
Phone: 404-686-2747
Email: vanessa.moll@emory.edu
Emory University Hospital Midtown
Status: Active
Contact: Vanessa Moll
Phone: 404-686-2747
Email: vanessa.moll@emory.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Optimize our intraoperative treatment protocol for head and neck cancer patients to reduce the incidence of delirium and associated postoperative cognitive dysfunction.

SECONDARY OBJECTIVES:

I. Determine the dose response relationship for intraoperative ketamine and delirium reduction.

II. Determine if a single dose of ketamine will reduce post-operative pain and opioid requirements.

III. Determine if raw electroencephalography (EEG) data can predict postoperative delirium during general anesthesia.

IV. Evaluate length of intensive care unit (ICU) and length of hospital stay (done by medical chart review).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive lower dose ketamine intravenously (IV) before surgery.

ARM II: Patients receive higher dose ketamine IV before surgery.

ARM III: Patients receive placebo IV before surgery.

After completion of study treatment, patients are followed up 2-6 weeks post-surgery.

Trial Phase & Type

Trial Phase

Phase IV

Trial Type

Treatment

Lead Organization

Lead Organization
Emory University Hospital / Winship Cancer Institute

Principal Investigator
Vanessa Moll

Trial IDs

Primary ID EU3268-16
Secondary IDs NCI-2017-00172, IRB00086609
Clinicaltrials.gov ID NCT03040024