Skip to main content
OpenTrials
Completed

NCT Number: NCT03553758

EEG Studies of Ketamine General Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Average Pain Intensity Pre- and Post-Ketamine Induction

    Time frame: Approximately 125 minutes

    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).

Secondary outcomes

  1. Average Dissociation States Score Pre- and Post-Ketamine Induction

    Time frame: About 125 minutes

    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).

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

    Time frame: About 60 minutes

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Electroencephalogram Studies of Induction and Recovery From Ketamine-Induced General Anesthesia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.