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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01339065
Enrollment
30
Registered
2011-04-20
Start date
2011-04-30
Completion date
2011-06-30
Last updated
2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Inflammatory Marker Levels

Keywords

ketamine, inflammatory, pro inflammatory, pro inflammatory markers IL-6 and IL-1beta

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.

Interventions

DRUGKetamine

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

Sponsors

Makerere University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
changes/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery48 hourschanges/deviations from baseline levels of IL-6 pro-inflammatory markers of after surgery at Post Anesthesia Care Unit, 24 and 48 hours

Secondary

MeasureTime frameDescription
changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery48 hourschanges/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours

Countries

Uganda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026