Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Phase 4

Completed

• Conditions: Respiratory Insufficiency; Respiration, Artificial; Conscious Sedation
• Interventions: Drug: remifentanil; Drug: placebo

• Registration Number: NCT00665119
• Lead Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Brief Summary

Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-17
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• pressure support ventilation or CPAP
• respiratory rate > 35.min-1
• respiratory rate/tidal volume > 105

Exclusion Criteria

• vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
• body temperature > 38 °C
• Glasgow Coma Scale < 9
• FIO2 > 0.6
• PEEP > 10 cmH2O
• pH < 7.30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment	placebo	Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions.
treatment	remifentanil	Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions.

Primary Outcome Measures

Name	Time	Method
respiratory rate/tidal volume	before and after remifentanil infusion; before and after placebo infusion.
pressure-time product	before and after remifentanil infusion; before and after placebo infusion.

Secondary Outcome Measures

Name	Time	Method
double product of respiratory system	before and after remifentanil infusion; before and after placebo infusion.
dynamic intrinsic PEEP	before and after remifentanil infusion; before and after placebo infusion.
adverse events	during all the study period
arterial pH	before and after remifentanil infusion; before and after placebo infusion.
level of sedation (RASS)	before and after remifentanil infusion; before and after placebo infusion.

Trial Locations

Locations (1)

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero; 🇮🇹 Brescia, Italy