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CompletedNCT02843698Updated Aug 29, 2017

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

A Phase 4 interventional study of Dexmedetomidine and Normal saline in Restrictive Lung Disease, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Restrictive Lung Disease

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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 42 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Control group

    Patients will receive normal saline

    Drug: Normal saline

Interventions

  • DrugDexmedetomidine

    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

    Also known as: Precedex

  • DrugNormal saline

    Normal saline

    Also known as: Saline

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What researchers measure

Primary outcomes

  1. Oxygenation

    assessed by P/F ratio

    Time frame: 2 hours

Secondary outcomes

  1. Lung mechanics

    lung compliance and dead space

    Time frame: 2 hours

  2. arterial blood pressure

    arterial blood pressure measured in mmHg

    Time frame: 2 hours

  3. plateau airway pressure

    plateau airway pressure measured in cmH2o

    Time frame: 2 hours

  4. heart rate

    number of heart beats per minute

    Time frame: 2 hours

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Study locations

1 site
  • Cairo University
    Cairo, Egypt
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References and documents

Publications

  • 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. PubMed 30103679 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02843698
Lead sponsor
Cairo University
Responsible party
Ahmed Hasanin (Lecturer of anesthesia and critical care medicine, Cairo University) — Principal investigator
First posted
Jul 26, 2016
Start date
Sep 2016
Primary completion
Aug 26, 2017
Completion
Aug 26, 2017
Last update
Aug 29, 2017

Study contacts

Ahmed Mukhtar, Professor
study director · Head of research committee section in anesthesia department

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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