Evaluation of the Effect of Different Doses Dexmedetomidine Infusion on Lung Mechanics and Oxygenation in Obese Patients

Study Overview
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Brief Summary
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• The objective of this study is to evaluate the effect of different doses of dexmedetomidine infusion intraoperative on lung mechanics and oxygenation regarding PaO2/Fraction of inspired oxygen), Intraoperative oxygenation, lung compliance (static and dynamic), dead space, and PaCO2,heart rate, mean arterial blood pressure in obese patients undergoing laparoscopic cancer surgeries

Detailed Description
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Dexmedetomidine is a selective agonist of α2receptorswhose tendency to α2 receptors is eight times more than that of clonidine. It also has powerful sedative, analgesic, anti-inﬂammatory, and organ protective properties. dexmedetomidine has favorable respiratory effects in humans. The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery. Morbidly obese patients are characterized by the high prevalence of restrictive lung disease.The study include 2 equal groups, each group is 35 patients: Group A(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (1μg/Kg LBW) bolus, followed by 0.5μg/Kg/hour continuous infusion till the end of surgery and Group B(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (0.5μg/Kg LBW) bolus, followed by 0.3μg/Kg/hour continuous infusion till the end of surgery.

Official Title
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Evaluation of the Effect of Different Doses Dexmedetomidine Infusion on Lung Mechanics and Oxygenation in Obese Patients Undergoing Laparoscopic Cancer Surgeries: A Randomized Controlled Trial

Conditions
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Obesity; Drug

Intervention / Treatment
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* Drug: Dexmedetomidine Injection [Precedex]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60years Obese patients BMI>25 Kg/meter square Patients undergoing laparoscopic cancer surgery. Exclusion Criteria: Heart failure Arrhythmias Severe liver or kidney impairment Patients with forced expiratory volume in 1 sec (FEV1)/FVC < 70% Heart block

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: The study include 2 equal groups, each group is 35 patients: Group A(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (1μg/Kg LBW) bolus, followed by 0.5μg/Kg/hour continuous infusion till the end of surgery and Group B(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (0.5μg/Kg LBW) bolus, followed by 0.3μg/Kg/hour continuous infusion till the end of surgery.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ( Group A)<br>: Group A(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (1μg/Kg LBW) bolus, followed by 0.5μg/Kg/hour continuous infusion till the end of surgery | Drug: Dexmedetomidine Injection [Precedex]<br>* two different doses dexmedetomidine bolus then maintenance infusion till end of surgeries and evaluation of lung mechanics and oxygenation<br>|
| Active Comparator: (Group B)<br>Group B(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (0.5μg/Kg LBW) bolus, followed by 0.3μg/Kg/hour continuous infusion till the end of surgery. | Drug: Dexmedetomidine Injection [Precedex]<br>* two different doses dexmedetomidine bolus then maintenance infusion till end of surgeries and evaluation of lung mechanics and oxygenation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation by the end study drug infusion | PaO2/Fraction of inspired oxygen | baseline and end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung compliance | static | baseline and end of surgery | 
| lung compliance | dynamic | baseline and end of surgery |