EEG Studies of Ketamine General Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553758
• Other study ID #: 2018P000417
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Ketamine
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Approximately 125 minutes
Secondary	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).	About 125 minutes
Secondary	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.	About 60 minutes