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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04730375
Enrollment
70
Registered
2021-01-29
Start date
2021-01-30
Completion date
2022-02-28
Last updated
2022-05-05

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

Conditions

Obesity; Drug

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.

Interventions

DRUGDexmedetomidine Injection [Precedex]

two different doses dexmedetomidine bolus then maintenance infusion till end of surgeries and evaluation of lung mechanics and oxygenation

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenation by the end study drug infusionbaseline and end of surgeryPaO2/Fraction of inspired oxygen

Secondary

MeasureTime frameDescription
lung compliancebaseline and end of surgerystatic

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026