Trial Outcomes & Findings for SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine (NCT NCT01250418)
NCT ID: NCT01250418
Last Updated: 2014-08-28
Results Overview
% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Intraoperative, an average of about 1 and 1/2 hours.
Results posted on
2014-08-28
Participant Flow
Participant milestones
| Measure |
Ketamine Group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
|
No Ketamine
No ketamine added to anesthesia regimen
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
16
|
|
Overall Study
COMPLETED
|
8
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Ketamine Group
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
|
No Ketamine
No ketamine added to anesthesia regimen
|
|---|---|---|
|
Overall Study
monitor data failure
|
1
|
1
|
Baseline Characteristics
SNAP VS BIS(OAA/S) Scale During a Sedation Regimen With and Without Ketamine
Baseline characteristics by cohort
| Measure |
Ketamine Group
n=9 Participants
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
|
No Ketamine
n=16 Participants
No ketamine added to anesthesia regimen
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=39 Participants
|
16 participants
n=41 Participants
|
25 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Intraoperative, an average of about 1 and 1/2 hours.% Time Tosca Monitor (TcCO2) above 50. A TcCo2 above 50 is indicative of hypoventilation.
Outcome measures
| Measure |
Ketamine Group
n=8 Participants
ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
|
No Ketamine
n=15 Participants
No ketamine added to anesthesia regimen
|
|---|---|---|
|
TcCO2 Above 50
|
39 Percent time intraoperatrive
Standard Deviation 26.54
|
30.8 Percent time intraoperatrive
Standard Deviation 26.14
|
Adverse Events
No Ketamine Added to Anesthesia Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place