A Phase 2/3 interventional study of Ketamine in Anesthesia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-26.
Sponsored by Massachusetts General Hospital · Phase 2/3, Interventional, and Basic science
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.
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.
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15 subjects undergoing ketamine general anesthesia.
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.
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).
Time frame: Approximately 125 minutes
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).
Time frame: About 125 minutes
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.
Time frame: About 60 minutes
| Milestone | Ketamine |
|---|---|
| Started | 16 |
| Completed screening visit | 16 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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).
| score on a scale | Ketamine EEG Dynamics |
|---|---|
| Pre-Ketamine | 7.9 ± 0.5 |
| 30 minutes Post-Ketamine | 1.6 ± 1.6 |
| 60 minutes Post-Ketamine | 4.1 ± 2.2 |
| 75 minutes Post-Ketamine | 4.3 ± 2.2 |
| 120 minutes Post-Ketamine | 5.4 ± 2.3 |
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).
| score on a scale | Ketamine |
|---|---|
| Pre-Ketamine | 0.2 ± 0.4 |
| 60 minutes post-ketamine | 22.1 ± 17 |
| 75 minutes post-ketamine | 14.3 ± 11.6 |
| 120 minutes post-ketamine | 5.2 ± 7.3 |
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.
| score on a scale | Ketamine |
|---|---|
| Difference of the Mean Clinician Administered Dissociative States Scale Before and After Midazolam Administration | 10.3 (3.4 to 17.1) |
Collected over From initiation of anesthesia during the first study visit to completion of the study visit, which was approximately 2 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
1 patient was enrolled in the study, but did not complete any study activities.
| Age, Categorical(Participants) | Ketamine |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | Ketamine |
|---|---|
| Mean | 24 ± 3.4 |
| Sex: Female, Male(Participants) | Ketamine |
|---|---|
| Female | 7 |
| Male | 8 |
| Ethnicity (NIH/OMB)(Participants) | Ketamine |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Ketamine |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Ketamine |
|---|---|
| United States | 15 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital