Trial Outcomes & Findings for The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (NCT NCT00978757)
NCT ID: NCT00978757
Last Updated: 2019-01-15
Results Overview
As an outcome, Interleukin 6 (IL-6) was measured in plasma concentration of hepatic resections requiring temporary porto-arterial occlusion patients.
COMPLETED
PHASE4
42 participants
Plasma concentration of IL-6 levels were obtained prior to surgery, upon placement of the first intravenous
2019-01-15
Participant Flow
Participant milestones
| Measure |
Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
|
Placebo
Placebo: saline solution
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
|
Placebo
Placebo: saline solution
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
3
|
Baseline Characteristics
The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion
Baseline characteristics by cohort
| Measure |
Ketamine
n=22 Participants
Ketamine: 0.25 mg/kg, intravenously, one dose.
|
Placebo
n=20 Participants
Placebo: saline solution
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 13.4 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 13.8 • n=107 Participants
|
61.23 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
22 participants
n=99 Participants
|
20 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Plasma concentration of IL-6 levels were obtained prior to surgery, upon placement of the first intravenousAs an outcome, Interleukin 6 (IL-6) was measured in plasma concentration of hepatic resections requiring temporary porto-arterial occlusion patients.
Outcome measures
| Measure |
Ketamine
n=22 Participants
Ketamine: 0.25 mg/kg, intravenously, one dose.
|
Placebo
n=20 Participants
Placebo: saline solution
|
|---|---|---|
|
The Effect of Ketamine on Interleukin 6 (IL-6) Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)
|
116.14 pg/ml
Standard Deviation 81.65
|
151.29 pg/ml
Standard Deviation 135.38
|
Adverse Events
Ketamine
Placebo
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