Clinical trial NCT01339065: The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital
Official title: The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post Operative Inflammatory Marker Levels
Keywords: ketamine
inflammatory
pro inflammatory
pro inflammatory markers IL-6 and IL-1beta
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery
timeFrame: 48 hours
Secondary outcomes:
measure: changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery
timeFrame: 48 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital National Refferal, surgical wards
Study officials:
References:
citation: 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.