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

Phase 4

• Conditions: Post Operative Inflammatory Marker Levels
• Interventions: Drug: Ketamine

• Registration Number: NCT01339065
• Lead Sponsor: Makerere University

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 Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-19
• Last Update Submitted: 2011-04-19
• Study First Posted: 2011-04-20
• Last Update Posted: 2011-04-20
• Primary Completion: 2011-05
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine	Ketamine	will be given low sub-anesthetic doses of Ketamine 0.5mg/kg.
Placebo	Ketamine	will get placebo treatment

Primary Outcome Measures

Name	Time	Method
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery	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

Secondary Outcome Measures

Name	Time	Method
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery	48 hours	changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours

Trial Locations

Locations (1)

Mulago Hospital National Refferal, surgical wards; 🇺🇬 Kampala, Uganda