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CompletedNCT02330120Updated Dec 10, 2015

Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics

A Phase 4 interventional study of propofol and dexmedetomidine in Abnormal Respiratory Airway Resistance, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-12-10.

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

Phase
Phase 4
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients.

Read the detailed description

The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this study. Patients are divided into two random groups, Group P (propofol) and Group D (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP, cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded. This parameters are evaluated with Drager Evita 4 ventilator and recorded on 5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and recorded.

The primary outcome measures are airway resistance and peak airway pressure. Secondary outcome measure is sedation score.

02

Conditions studied

  • Abnormal Respiratory Airway Resistance

Keywords

  • peak airway pressure
  • airway resistance
  • sedation
  • intensive care
03

In context

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • The patients mechanically ventilated in intensive care unit

Exclusion criteria

Exclusion Criteria:

  • Patients with contraindications for using propofol and dexmedetomidine
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    propofol

    Propofol infusion 0.5-2 mg/kg/h for sedation in mechanically ventilated patients

    Drug: propofol

  • Active comparator
    dexmedetomidine

    dexmedetomidine infusion 0.2-0.7 mcg/kg/h for sedation in mechanically ventilated patients

    Drug: dexmedetomidine

Interventions

  • Drugpropofol
  • Drugdexmedetomidine
06

What researchers measure

Primary outcomes

  1. airway resistance

    airway resistans measured by Evita 4 ventilator flow sensor

    Time frame: 60 minutes

  2. peak airway pressure values

    peak airway pressure values provide the methods used to Evita 4 ventilator flow sensor

    Time frame: 60 minutes

07

Study locations

1 site
  • Cukurova University
    Adana, 01130, Turkey
08

References and documents

Publications

  • Fernandes FC, Ferreira HC, Cagido VR, Carvalho GM, Pereira LS, Faffe DS, Zin WA, Rocco PR. Effects of dexmedetomidine on respiratory mechanics and control of breathing in normal rats. Respir Physiol Neurobiol. 2006 Dec;154(3):342-50. doi: 10.1016/j.resp.2006.02.002. Epub 2006 Mar 9. PubMed 16527548 ↗
  • Bang SR, Lee SE, Ahn HJ, Kim JA, Shin BS, Roe HJ, Sim WS. Comparison of respiratory mechanics between sevoflurane and propofol-remifentanil anesthesia for laparoscopic colectomy. Korean J Anesthesiol. 2014 Feb;66(2):131-5. doi: 10.4097/kjae.2014.66.2.131. Epub 2014 Feb 28. PubMed 24624271 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2015, 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
NCT02330120
Lead sponsor
Cukurova University
Responsible party
mediha turktan (Cukurova University, Cukurova University) — Principal investigator
First posted
Jan 1, 2015
Start date
Jan 2011
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Dec 10, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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