An interventional study of Ketamine group in Pain, sponsored by Northwestern University. Terminated at 1 site in United States. Open to female participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-08-28.
Sponsored by Northwestern University · Not applicable, Interventional, and Basic science
The study question: Does the SNAP-Index (SI) correlates better with the OASS than the BIS Monitor during sedation with ketamine?
The study hypothesis: Since the SNAP II monitor seems to be more responsive during emergence of anesthesia, it will have a better correlation with the OASS than the BIS monitor with the use of ketamine.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drop-out criteria:
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Drug: Ketamine group
No ketamine added to anesthesia regimen
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
TcCO2 Above 50
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
Time frame: Intraoperative, an average of about 1 and 1/2 hours.
| Milestone | Ketamine Group | No Ketamine |
|---|---|---|
| Started | 9 | 16 |
| Completed | 8 | 15 |
| Not completed | 1 | 1 |
| Withdrew: Monitor data failure | 1 | 1 |
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
| Percent time intraoperatrive | Ketamine Group | No Ketamine |
|---|---|---|
| TcCO2 Above 50 | 39 ± 26.54 | 30.8 ± 26.14 |
Collected over 24 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Ketamine Added to Anesthesia Regimen | — | 0/16 (0%) | 0/16 (0%) |
| Ketamine Group | — | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Ketamine Group | No Ketamine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 16 | 25 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ketamine Group | No Ketamine | Total |
|---|---|---|---|
| Female | 9 | 16 | 25 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ketamine Group | No Ketamine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 4 | 5 |
| White | 8 | 11 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ketamine Group | No Ketamine | Total |
|---|---|---|---|
| United States | 9 | 16 | 25 |
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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