Phase 3 N=16 Basic Science

EEG Studies of Ketamine General Anesthesia

Anesthesia

Bottom Line

View on ClinicalTrials.gov: NCT03553758 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2020

Primary outcome: Primary: Average Pain Intensity Pre- and Post-Ketamine Induction — 7.9; 1.6; 4.1; 4.3 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ketamine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Pain Intensity Pre- and Post-Ketamine Induction	7.9; 1.6; 4.1; 4.3; 5.4	—
SECONDARY Average Dissociation States Score Pre- and Post-Ketamine Induction	0.2; 22.1; 14.3; 5.2	—
SECONDARY Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration	10.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03553758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.