Clinical trial NCT04730375: Evaluation of the Effect of Different Doses Dexmedetomidine Infusion on Lung Mechanics and Oxygenation in Obese Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity; Drug
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: • 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygenation by the end study drug infusion
timeFrame: baseline and end of surgery
Secondary outcomes:
measure: lung compliance
timeFrame: baseline and end of surgery
measure: lung compliance
timeFrame: baseline and end of surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nataional Cancer Instituite
Study officials:
affiliation: National Cancer Institute (NCI)
name: Mohamed abdel wadod, MD
role: PRINCIPAL_INVESTIGATOR
References: