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

Phase 2

Completed

• Conditions: Obesity; Drug
• Interventions: Drug: Dexmedetomidine Injection [Precedex]

• Registration Number: NCT04730375
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-01-29
• Study Start: 2021-01-30
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(Group B)	Dexmedetomidine Injection [Precedex]	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.
( Group A)	Dexmedetomidine Injection [Precedex]	: 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

Primary Outcome Measures

Name	Time	Method
Oxygenation by the end study drug infusion	baseline and end of surgery	PaO2/Fraction of inspired oxygen

Secondary Outcome Measures

Name	Time	Method
lung compliance	baseline and end of surgery	dynamic

Trial Locations

Locations (1)

Nataional Cancer Instituite; 🇪🇬 Cairo, Egypt