The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 19, 2011
CompletedFirst Posted
Study publicly available on registry
April 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 20, 2011
April 1, 2011
1 month
April 19, 2011
April 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery
48 hours
Study Arms (2)
Ketamine
ACTIVE COMPARATORwill be given low sub-anesthetic doses of Ketamine 0.5mg/kg.
Placebo
PLACEBO COMPARATORwill get placebo treatment
Interventions
determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mulago Hospital National Refferal, surgical wards
Kampala, +256, Uganda
Related Publications (1)
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.
PMID: 29062346DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 19, 2011
First Posted
April 20, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2011
Study Completion
June 1, 2011
Last Updated
April 20, 2011
Record last verified: 2011-04