Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Overview

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.

Full Title of Study: “Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

Interventions

  • Drug: remifentanil
    • 0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion
  • Drug: placebo
    • NaCl 0.9 %

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Provider of Information About this Clinical Study
    • Natalini Giuseppe, FPoliambulanza
  • Overall Official(s)
    • Giuseppe Natalini, MD, Principal Investigator, Fondazione Poliambulanza Istituto Ospedaliero

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.