Phase 3
Completed N=16
EEG Studies of Ketamine General Anesthesia
Anesthesia
Source: ClinicalTrials.gov NCT03553758 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Average Pain Intensity Pre- and Post-Ketamine Induction — 7.9; 1.6; 4.1; 4.3 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.