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Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843698
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients

Condition or disease Intervention/treatment Phase
Restrictive Lung Disease Drug: Dexmedetomidine Drug: Normal saline Phase 4

Detailed Description:
The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 26, 2017
Actual Study Completion Date : August 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arm Intervention/treatment
Experimental: Dexmedetomidine group
Patients will receive either, Dexmedetomidine (Precedex, Hospira, Lake forest, IL, USA) in a dose of (1ug/Kg LBW) bolus followed by 0.5ug/Kg continuous infusion for one hour
Drug: Dexmedetomidine
Dexmedetomidine infusion was previously reported to improve oxygenation and lung dynamics in patients with obstructive lung diseases. In our study we are going to investigate its effect on oxygenation and lung dynamics in restrictive lung disease
Other Name: Precedex

Placebo Comparator: Control group
Patients will receive normal saline
Drug: Normal saline
Normal saline
Other Name: Saline




Primary Outcome Measures :
  1. Oxygenation [ Time Frame: 2 hours ]
    assessed by P/F ratio


Secondary Outcome Measures :
  1. Lung mechanics [ Time Frame: 2 hours ]
    lung compliance and dead space

  2. arterial blood pressure [ Time Frame: 2 hours ]
    arterial blood pressure measured in mmHg

  3. plateau airway pressure [ Time Frame: 2 hours ]
    plateau airway pressure measured in cmH2o

  4. heart rate [ Time Frame: 2 hours ]
    number of heart beats per minute



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Morbid obese (body mass index > 40) with documented restrictive lung disease scheduled to bariatric operation.

Exclusion Criteria:

  • Heart failure
  • ِِِِArrhythmia
  • Heart block
  • Severe liver or kidney impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843698


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed Mukhtar, Professor Head of research committee section in anesthesia department
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmed Hasanin, Lecturer of anesthesia and critical care medicine, Cairo University
ClinicalTrials.gov Identifier: NCT02843698    
Other Study ID Numbers: N-12-2016
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action