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Completed

NCT Number: NCT00665119

Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

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.

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Key information

Conditions

Respiratory Insufficiency Conscious Sedation Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

0.05 mcg.kg-1.min-1 for 30 minutes by continuous endovenous infusion

Placebo

Drug

NaCl 0.9 %

Primary outcomes

  1. respiratory rate/tidal volume

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

  2. pressure-time product

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

Secondary outcomes

  1. double product of respiratory system

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

  2. dynamic intrinsic PEEP

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

  3. adverse events

    Time frame: during all the study period

  4. arterial pH

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

  5. level of sedation (RASS)

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

Sponsors and collaborators

Lead sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 23, 2008
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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