EEG Studies of Ketamine General Anesthesia

NCT03553758 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2018P000417
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

We are doing this research study to find out how and where ketamine acts in the brain. Ketamine is an anesthetic (a drug or agent used to decrease or eliminate the feeling of pain by putting you in an unconscious state). We will look at the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG). We will assess how it impacts patient's pain responses.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Average Pain Intensity Pre- and Post-Ketamine Induction

  Average Pain Intensity prior to ketamine induction, 30 minutes post ketamine, 60 minutes post ketamine, 75 minutes post ketamine, and 120 minutes post ketamine. PROMIS Pain Intensity 1a was used to assess pain delivered by a pre-calibrated pain cuff. Scale of 0 (no pain) to 10 (worst imaginable pain).

  Approximately 125 minutes

Secondary Outcomes (2)

• Average Dissociation States Score Pre- and Post-Ketamine Induction

  About 125 minutes

• Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration

  About 60 minutes

Study Arms (1)

Ketamine

EXPERIMENTAL

15 subjects undergoing ketamine general anesthesia.

Drug: Ketamine

Interventions

Ketamine DRUG

Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.

Ketamine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 to 45
• Normal body weight and habitus, BMI less than or equal to 30
• Non-smoker
• American Society of Anesthesiologists (ASA) physical status classification P1

You may not qualify if:

• Cardiovascular: myocardial infarction, coronary artery disease, peripheral vascular disease, arrhythmia, congestive heart failure, valvular disease, hypertension
• Respiratory: bronchitis, chronic obstructive pulmonary disease, smoking, shortness of breath
• Hepatic: hepatitis, jaundice, ascites
• Neurologic: seizure, stroke, positive neurologic findings on neurologic examination, multiple sclerosis, Meniere's disease, Parkinson's disease, neuropathy, peripheral stenosis
• Gastrointestinal: esophageal reflux, hiatal hernia, ulcer
• Endocrine: diabetes, thyroid disease
• Renal: acute or chronic severe renal insufficiency
• Hematologic: blood dyscrasias, anemia, coagulopathies, on anticoagulant therapy
• Musculoskeletal: prior surgery or trauma to head neck or face, arthritis, personal or family history of malignant hyperthermia
• Psychiatric: history or treatment for an active psychiatric problem, depression
• Reproductive: pregnancy, breast-feeding
• Medications: regular use of prescription and non-prescription medications expected to affect CNS function, St. John's Wort
• Allergies: labetalol, ondansetron, glycopyrrolate, ketamine, midazolam

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Oluwaseun Johnson-Akeju
• Organization: Massachusetts General Hospital DACCPM

oluwaseun.akeju@mgh.harvard.edu

617-724-7200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: June 12, 2018
• Study Start: November 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Locations

US (1)