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The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital

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ClinicalTrials.gov Identifier: NCT01339065
Recruitment Status : Unknown
Verified April 2011 by Makerere University.
Recruitment status was:  Recruiting
First Posted : April 20, 2011
Last Update Posted : April 20, 2011
Sponsor:
Information provided by:
Makerere University

Brief Summary:

. Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.

. Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the levels of IL-6 & IL-1β pro inflammatory markers by 48 hours.


Condition or disease Intervention/treatment Phase
Post Operative Inflammatory Marker Levels Drug: Ketamine Phase 4

Detailed Description:

RESEARCH QUESTION Can 0.5mg/kg of Ketamine given preoperatively have an effect on the levels of pro-inflammatory markers?

Primary specific Outcome: changes/deviations from baseline levels of IL- 6 pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.

Secondary specific Outcome: changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
Study Start Date : April 2011
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine
will be given low sub-anesthetic doses of Ketamine 0.5mg/kg.
Drug: Ketamine
determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients

Placebo Comparator: Placebo
will get placebo treatment
Drug: Ketamine
determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients




Primary Outcome Measures :
  1. changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery [ Time Frame: 48 hours ]
    changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours


Secondary Outcome Measures :
  1. changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery [ Time Frame: 48 hours ]
    changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consented patients due for elective surgery
  • Adult patients 18- 70 year old
  • ASA I- ASA II scoring patients, who are normal patients or those with mild systemic illness

Exclusion Criteria:

  • Emergency cases that will already have high levels of inflammatory markers secreted in their system by incision time e.g. road traffic accidents
  • Patients with chronic / severe hypertension
  • Febrile Patients (T >38°C)
  • Persistently raised blood pressures above 140/90 for 2 consistent readings 15 minutes apart
  • Patients with pheochromocytoma
  • Spinal and local infiltration anaesthesia cases
  • Neuro surgery patients whom Ketamine is contra indicated
  • Epilepsy patients
  • ASA IIIE and above
  • Patients receiving Aspirin prophylaxis
  • Chronic inflammatory disease states such as hyperparathyroidism

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339065


Locations
Uganda
Mulago Hospital National Refferal, surgical wards Recruiting
Kampala, Uganda, +256
Contact: John M Kasumba, MBChB, MMed Anaesthesia- MUK    +25675625678 ext +256701625678    drkasmaya@gmail.com   
Principal Investigator: Tonny S Luggya, MBChB- MUK         
Sponsors and Collaborators
Makerere University

Responsible Party: Dr luggya Tonny Stone, Makerere University, College Of Health Sciences
ClinicalTrials.gov Identifier: NCT01339065     History of Changes
Other Study ID Numbers: MUK CHS
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: April 2011

Keywords provided by Makerere University:
ketamine
inflammatory
pro inflammatory
pro inflammatory markers IL-6 and IL-1beta

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action