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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

Brief Summary

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. 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.

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Detailed Description

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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.

Conditions

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Post Operative Inflammatory Marker Levels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ketamine

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

Placebo

will get placebo treatment

Group Type PLACEBO_COMPARATOR

Ketamine

Intervention Type DRUG

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

Interventions

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Ketamine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes