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Clinical Trials/NCT04730375
NCT04730375
Completed
Phase 2

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

National Cancer Institute, Egypt1 site in 1 country70 target enrollmentJanuary 30, 2021

Overview

Phase
Phase 2
Intervention
Dexmedetomidine Injection [Precedex]
Conditions
Obesity; Drug
Sponsor
National Cancer Institute, Egypt
Enrollment
70
Locations
1
Primary Endpoint
Oxygenation by the end study drug infusion
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2021
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Mohammed Abdelfattah Abdelwadod

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

National Cancer Institute, Egypt

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

Arms & Interventions

( 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

Intervention: Dexmedetomidine Injection [Precedex]

(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.

Intervention: Dexmedetomidine Injection [Precedex]

Outcomes

Primary Outcomes

Oxygenation by the end study drug infusion

Time Frame: baseline and end of surgery

PaO2/Fraction of inspired oxygen

Secondary Outcomes

  • lung compliance(baseline and end of surgery)

Study Sites (1)

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