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NCT00665119 Clinical Trial

Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Respiratory Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00665119
Other study ID # FP-TIP-01
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2008
Last updated December 17, 2008
Start date April 2008
Est. completion date October 2008

Study information
Verified date December 2008
Source Fondazione Poliambulanza Istituto Ospedaliero
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero Brescia

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary respiratory rate/tidal volume before and after remifentanil infusion; before and after placebo infusion. No
Primary pressure-time product before and after remifentanil infusion; before and after placebo infusion. No
Secondary double product of respiratory system before and after remifentanil infusion; before and after placebo infusion. No
Secondary dynamic intrinsic PEEP before and after remifentanil infusion; before and after placebo infusion. No
Secondary adverse events during all the study period Yes
Secondary arterial pH before and after remifentanil infusion; before and after placebo infusion. Yes
Secondary level of sedation (RASS) before and after remifentanil infusion; before and after placebo infusion. Yes
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