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

NCT04730375 | Completed Phase 2

• 1 other identifier: AP2007-50109
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Drug

Outcome Measures

Primary Outcomes (1)

• Oxygenation by the end study drug infusion

  PaO2/Fraction of inspired oxygen

  baseline and end of surgery

Secondary Outcomes (2)

• lung compliance

  baseline and end of surgery

• lung compliance

  baseline and end of surgery

Study Arms (2)

( Group A)

ACTIVE COMPARATOR

: 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

Drug: Dexmedetomidine Injection [Precedex]

(Group B)

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine Injection [Precedex]

Interventions

Dexmedetomidine Injection [Precedex] DRUG

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

( Group A); (Group B)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60years
• Obese patients BMI\>25 Kg/meter square
• Patients undergoing laparoscopic cancer surgery.

You may not qualify if:

• Heart failure
• Arrhythmias
• Severe liver or kidney impairment
• Patients with forced expiratory volume in 1 sec (FEV1)/FVC \< 70%
• Heart block

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Nataional Cancer Instituite

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed abdel wadod, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Model Details: 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 Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: January 30, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Locations

EG (1)