NCT02330120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

4.6 years

First QC Date

November 17, 2014

Last Update Submit

December 9, 2015

Conditions

Abnormal Respiratory Airway Resistance

Keywords

peak airway pressureairway resistancesedationintensive care

Outcome Measures

Primary Outcomes (2)

  • airway resistance

    airway resistans measured by Evita 4 ventilator flow sensor

    60 minutes

  • peak airway pressure values

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

    60 minutes

Study Arms (2)

propofol

EXPERIMENTAL

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

Drug: propofol

dexmedetomidine

ACTIVE COMPARATOR

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

Drug: dexmedetomidine

Interventions

propofolDRUG
propofol
dexmedetomidineDRUG
dexmedetomidine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients mechanically ventilated in intensive care unit

You may not qualify if:

  • Patients with contraindications for using propofol and dexmedetomidine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 16527548BACKGROUND

  • 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.

    PMID: 24624271BACKGROUND

MeSH Terms

Interventions

PropofolDexmedetomidine

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cukurova University

Study Record Dates

First Submitted

November 17, 2014

First Posted

January 1, 2015

Study Start

January 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

TU(1)