Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations
Primary Purpose
Restrictive Lung Disease
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Restrictive Lung Disease
Eligibility 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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexmedetomidine group
Control group
Arm Description
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
Patients will receive normal saline
Outcomes
Primary Outcome Measures
Oxygenation
assessed by P/F ratio
Secondary Outcome Measures
Lung mechanics
lung compliance and dead space
arterial blood pressure
arterial blood pressure measured in mmHg
plateau airway pressure
plateau airway pressure measured in cmH2o
heart rate
number of heart beats per minute
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02843698
Brief Title
Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations
Official Title
Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 26, 2017 (Actual)
Study Completion Date
August 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restrictive Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Saline
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
Oxygenation
Description
assessed by P/F ratio
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Lung mechanics
Description
lung compliance and dead space
Time Frame
2 hours
Title
arterial blood pressure
Description
arterial blood pressure measured in mmHg
Time Frame
2 hours
Title
plateau airway pressure
Description
plateau airway pressure measured in cmH2o
Time Frame
2 hours
Title
heart rate
Description
number of heart beats per minute
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mukhtar, Professor
Organizational Affiliation
Head of research committee section in anesthesia department
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30103679
Citation
Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y.
Results Reference
derived
Learn more about this trial
Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations
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