Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics

Phase 4

Completed

• Conditions: Abnormal Respiratory Airway Resistance
• Interventions: Drug: dexmedetomidine; Drug: propofol

• Registration Number: NCT02330120
• Lead Sponsor: Cukurova University

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-12-31
• Study First Posted: 2015-01-01
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• The patients mechanically ventilated in intensive care unit

Exclusion Criteria

• Patients with contraindications for using propofol and dexmedetomidine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine	dexmedetomidine	dexmedetomidine infusion 0.2-0.7 mcg/kg/h for sedation in mechanically ventilated patients
propofol	propofol	Propofol infusion 0.5-2 mg/kg/h for sedation in mechanically ventilated patients

Primary Outcome Measures

Name	Time	Method
airway resistance	60 minutes	airway resistans measured by Evita 4 ventilator flow sensor
peak airway pressure values	60 minutes	peak airway pressure values provide the methods used to Evita 4 ventilator flow sensor

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey