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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Makerere University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT01339065
First received: April 19, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

. 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 Intervention Phase
Post Operative Inflammatory Marker Levels
 Drug: Ketamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Makerere University:

Primary Outcome Measures:
  • changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    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:
  • changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 19, 2011
Last Updated: April 19, 2011
Health Authority: Uganda: Makerere University

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

Additional relevant MeSH terms:
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 23, 2013