Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations
1 other identifier
interventional
42
1 country
1
Brief Summary
The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2016
CompletedFirst Posted
Study publicly available on registry
July 26, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2017
CompletedAugust 29, 2017
August 1, 2017
12 months
July 20, 2016
August 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Oxygenation
assessed by P/F ratio
2 hours
Secondary Outcomes (4)
Lung mechanics
2 hours
arterial blood pressure
2 hours
plateau airway pressure
2 hours
heart rate
2 hours
Study Arms (2)
Dexmedetomidine group
EXPERIMENTALPatients 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
Control group
PLACEBO COMPARATORPatients will receive normal saline
Interventions
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
Eligibility Criteria
You may qualify if:
- \- Morbid obese (body mass index \> 40) with documented restrictive lung disease scheduled to bariatric operation.
You may not qualify if:
- Heart failure
- ِِِِArrhythmia
- Heart block
- Severe liver or kidney impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (1)
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.
PMID: 30103679DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Mukhtar, Professor
Head of research committee section in anesthesia department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia and critical care medicine
Study Record Dates
First Submitted
July 20, 2016
First Posted
July 26, 2016
Study Start
September 1, 2016
Primary Completion
August 26, 2017
Study Completion
August 26, 2017
Last Updated
August 29, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share