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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

Tracking Information
First Submitted Date  ICMJE April 19, 2011
First Posted Date  ICMJE April 20, 2011
Last Update Posted Date April 20, 2011
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital
Official Title  ICMJE The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Condition  ICMJE Post Operative Inflammatory Marker Levels
Intervention  ICMJE Drug: Ketamine
determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
Study Arms  ICMJE
  • Active Comparator: Ketamine
    will be given low sub-anesthetic doses of Ketamine 0.5mg/kg.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    will get placebo treatment
    Intervention: Drug: Ketamine
Publications * Luggya TS, Roche T, Ssemogerere L, Kintu A, Kasumba JM, Kwizera A, Tindimwebwa JV. Effect of low-dose ketamine on post-operative serum IL-6 production among elective surgical patients: a randomized clinical trial. Afr Health Sci. 2017 Jun;17(2):500-507. doi: 10.4314/ahs.v17i2.25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01339065
Other Study ID Numbers  ICMJE MUK CHS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr luggya Tonny Stone, Makerere University, College Of Health Sciences
Study Sponsor  ICMJE Makerere University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Makerere University
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP