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

Post Operative Inflammatory Marker Levels Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01339065
• Other study ID #: MUK CHS
• Status: Recruiting
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: April 19, 2011
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: April 2011
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Makerere University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Post Operative Inflammatory Marker Levels

Intervention

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

Locations

Country	Name	City	State
Uganda	Mulago Hospital National Refferal, surgical wards	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	changes/deviations from baseline levels of IL-1ß pro-inflammatory markers of after surgery	changes/deviations from baseline levels of IL-1ß pro-inflammatory markers of after surgery at PACU, 24 and 48 hours	48 hours	Yes