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Clinical Trials/NCT00665119
NCT00665119
Completed
Phase 4

Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.

Fondazione Poliambulanza Istituto Ospedaliero1 site in 1 country14 target enrollmentApril 2008

Overview

Phase
Phase 4
Intervention
remifentanil
Conditions
Respiratory Insufficiency
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Enrollment
14
Locations
1
Primary Endpoint
respiratory rate/tidal volume
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
October 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Fondazione Poliambulanza Istituto Ospedaliero

Eligibility Criteria

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

Arms & Interventions

treatment

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.

Intervention: remifentanil

treatment

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.

Intervention: placebo

Outcomes

Primary Outcomes

respiratory rate/tidal volume

Time Frame: before and after remifentanil infusion; before and after placebo infusion.

pressure-time product

Time Frame: before and after remifentanil infusion; before and after placebo infusion.

Secondary Outcomes

  • 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.)

Study Sites (1)

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