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

NCT ID: NCT04730375

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-30
• Study Completion Date: 2022-02-28

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.

Conditions

Obesity; Drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

( Group A)

: 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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type: DRUG

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

(Group B)

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 Type: ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type: DRUG

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

Interventions

Dexmedetomidine Injection [Precedex]

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abdelfattah Abdelwadod

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed abdel wadod, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Nataional Cancer Instituite

Cairo, , Egypt

Countries

Egypt

Other Identifiers

AP2007-50109

Identifier Type: -

Identifier Source: org_study_id