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

Makerere University30 enrolled

Overview

. 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.

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

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Post Operative Inflammatory Marker Levels

Interventions

KetamineDRUG

determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mulago Hospital National Refferal, surgical wards

Kampala, Uganda

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

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

Time frame: 48 hours

Data from ClinicalTrials.gov

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