The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion
Phase 4: Study of Ketamine Inhibition of Interleukin 6 in Hepatic Resections Requiring Temporary Porto-arterial Occlusion
1 other identifier
interventional
42
1 country
1
Brief Summary
The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2001
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 16, 2009
CompletedFirst Posted
Study publicly available on registry
September 17, 2009
CompletedResults Posted
Study results publicly available
January 18, 2010
CompletedJanuary 15, 2019
March 1, 2018
7 years
September 16, 2009
September 23, 2009
December 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Effect of Ketamine on Interleukin 6 (IL-6) Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)
As an outcome, Interleukin 6 (IL-6) was measured in plasma concentration of hepatic resections requiring temporary porto-arterial occlusion patients.
Plasma concentration of IL-6 levels were obtained prior to surgery, upon placement of the first intravenous
Study Arms (2)
Ketamine
EXPERIMENTALKetamine: 0.25 mg/kg, intravenously, one dose.
Placebo
PLACEBO COMPARATORPlacebo: saline solution
Interventions
Eligibility Criteria
You may qualify if:
- Age: 21 or older
- Planned liver resection with Pringle maneuver lasting 30-60 minutes
You may not qualify if:
- Chronic illness requiring corticosteroids
- Cirrhosis
- Hemodynamic instability prior to surgery
- Diabetes
- Sepsis
- Surgical interventions or chemotherapy treatments within the past 30 days
- Pregnancy
- Illnesses that could potentially affect the hepatic circulation
- Arterial hypertension
- Ocular hypertension
- Allergy to ketamine
- Preoperative portal embolization
- Radiofrequency ablation
- Patients requiring emergency surgeries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Italiano de Buenos Aires
Buenos Aires, 1181, Argentina
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- MD
- Organization
- Francisco C. Bonofiglio
Study Officials
- PRINCIPAL INVESTIGATOR
Francisco C Bonofiglio, MD PhD
Hospital Italiano of Buenos Aires, Argentina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
September 16, 2009
First Posted
September 17, 2009
Study Start
June 1, 2001
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
January 15, 2019
Results First Posted
January 18, 2010
Record last verified: 2018-03