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EEG Studies of Ketamine General Anesthesia

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Mass General Brigham

Status and phase

Completed
Phase 3
Phase 2

Conditions

Anesthesia

Treatments

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT03553758
2018P000417

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

16 participants in 1 patient group

Ketamine
Experimental group
Description:
15 subjects undergoing ketamine general anesthesia.
Treatment:
Drug: Ketamine

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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