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

Study Overview
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Brief Summary
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. 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
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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.

Official Title
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The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial

Conditions
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Post Operative Inflammatory Marker Levels

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine<br>will be given low sub-anesthetic doses of Ketamine 0.5mg/kg. | Drug: Ketamine<br>* determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients<br>|
| Placebo Comparator: Placebo<br>will get placebo treatment | Drug: Ketamine<br>* determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery | changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery | changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketamine, inflammatory, pro inflammatory, pro inflammatory markers IL-6 and IL-1beta