Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Condition(s) targeted: Respiratory Insufficiency; Respiration, Artificial; Conscious Sedation

Intervention: remifentanil (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Fondazione Poliambulanza Istituto Ospedaliero

Official(s) and/or principal investigator(s):
Giuseppe Natalini, MD, Principal Investigator, Affiliation: Fondazione Poliambulanza Istituto Ospedaliero

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

respiratory rate/tidal volume

pressure-time product

Secondary outcome:

double product of respiratory system

dynamic intrinsic PEEP

adverse events

arterial pH

level of sedation (RASS)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero, Brescia 25124, Italy

Starting date: April 2008
Last updated: December 17, 2008