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The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion

This study has been completed.
Sponsor:
Information provided by:
Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT00978757
First received: September 16, 2009
Last updated: December 11, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatectomy
 Drug: Ketamine
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4: Study of Ketamine Inhibition of Interleukin 6 in Hepatic Resections Requiring Temporary Porto-arterial Occlusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver) [ Time Frame: Blood samples for IL-6 levels were obtained prior to surgery, upon placement of the first intravenous ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: June 2001
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
 Drug: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
Other Name: Ketamine commercially available - FADA Pharma
Placebo Comparator: Placebo
Placebo: saline solution
 Other: Placebo
saline solution
Other Name: Normal saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 21 or older
  • Planned liver resection with Pringle maneuver lasting 30-60 minutes

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978757

Locations
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina, 1181
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Francisco C Bonofiglio, MD PhD Hospital Italiano of Buenos Aires, Argentina
  More Information

No publications provided

Responsible Party: Hospital Italiano of Buenos Aires, Argentina, Hospital Italiano of Buenos Aires, Argentina
ClinicalTrials.gov Identifier: NCT00978757     History of Changes
Other Study ID Numbers: IRB#556
Study First Received: September 16, 2009
Results First Received: September 23, 2009
Last Updated: December 11, 2009
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital Italiano de Buenos Aires:
hepatectomy
IL 6
organ failure
ketamine
Pringle

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013