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Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics

NCT ID: NCT02330120

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Abnormal Respiratory Airway Resistance

Keywords

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peak airway pressure airway resistance sedation intensive care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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propofol

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

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

Interventions

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propofol

Intervention Type DRUG

dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The patients mechanically ventilated in intensive care unit

Exclusion Criteria

* Patients with contraindications for using propofol and dexmedetomidine
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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mediha turktan

Cukurova University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16527548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24624271 (View on PubMed)

Other Identifiers

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intensive care

Identifier Type: -

Identifier Source: org_study_id