Immunomodulatory Effects of Dexmedetomidine Infusion

Study Overview
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Brief Summary
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Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality

Official Title
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Immunomodulatory Effects of Dexmedetomidine Infusion After Laparoscopic Major Abdominal Surgeries: Randomized Controlled Study

Conditions
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Major Abdominal Surgery

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for elective laparoscopic major abdominal surgeries; ASA class II-III Exclusion Criteria: - 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist. 6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine group<br>patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h. | Drug: Dexmedetomidine<br>* patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h.<br>|
| Placebo Comparator: Control group<br>patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion | Drug: 0.9% sodium chloride<br>* patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune-modulatory effects | serum concentrations of C-reactive protein (CRP) level ,The pro-inflammatory cytokines interleukin (IL)-1β, and IL-6 and anti-inflammatory cytokines IL-10 will be measured at four times: T0 (before anesthesia), T1 (1 h after surgery), T2 (24 h after surgery) and T4 (72 h after surgery | three days after surgery |