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

Makerere University

Status and phase: Unknown; Phase 4

Conditions: Post Operative Inflammatory Marker Levels

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01339065

MUK CHS

Details and patient eligibility

About

. 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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups, including a placebo group

Ketamine

Active Comparator group

Description:

will be given low sub-anesthetic doses of Ketamine 0.5mg/kg.

Treatment:

Drug: Ketamine

Placebo

Placebo Comparator group

Description:

will get placebo treatment

Treatment:

Drug: Ketamine