EEG Studies of Ketamine General Anesthesia

Massachusetts General Hospital16 enrolled

Overview

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.

In this trial, participants will be given ketamine at a high enough dosage to induce general anesthesia. EEG recording will be conducted during this time. Cognitive assessments and pain monitoring will be administered at various points before and after ketamine induction.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Anesthesia

Interventions

KetamineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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).

Time frame: Approximately 125 minutes

Secondary Outcomes

Average Dissociation States Score Pre- and Post-Ketamine Induction

Patients were assessed for dissociation states prior to the induction of ketamine and at 60 minutes, 75 minutes, and 120 minutes after Ketamine was administered. The Clinician Administered Dissociation States Scale was used to measure dissociation. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation).

Time frame: About 125 minutes

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

Midazolam was administered approximately 60 minutes after the administration of Ketamine in order to reduce the effects of Ketamine on dissociation. Dissociation was measured using the Clinician Administered Dissociative States Scale. Each section is scored 0 (not at all) to 4 (extreme), and totaled. The minimum total score is 0 (best, no dissociation at all) and the maximum total score is 92 (worst, the most dissociation). The difference of the mean Clinician Administered Dissociative States Scale before and after Midazolam administration was found.

Time frame: About 60 minutes

Data from ClinicalTrials.gov

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