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).
EEG Studies of Ketamine General Anesthesia
Brief 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.
Intervention / Treatment
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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.
Condition or Disease
- Anesthesia
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 45 Years |
| Enrollment: | 16 (ACTUAL) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Basic Science |
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Clinical Trial Dates
| Start date: | Nov 01, 2018 | ACTUAL |
|---|---|---|
| Primary Completion: | Feb 01, 2019 | ACTUAL |
| Completion Date: | Aug 01, 2019 | ACTUAL |
| Study First Posted: | Jun 12, 2018 | ACTUAL |
| Results First Posted: | Aug 26, 2020 | ACTUAL |
| Last Updated: | Aug 14, 2020 |
Sponsors / Collaborators
Lead Sponsor:
Massachusetts General Hospital
Responsible Party:
N/A
Location
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.
Participant Groups
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15 subjects undergoing ketamine general anesthesia.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 45 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
Secondary Outcomes
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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).
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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.
More Details
| NCT Number: | NCT03553758 |
|---|---|
| Other IDs: | 2018P000417 |
| Study URL: | https://clinicaltrials.gov/study/NCT03553758 |
Last updated: Sep 29, 2023