Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665119

Enrollment

Registered

2008-04-23

Start date

2008-04-30

Completion date

2008-10-31

Last updated

2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation, Respiration, Artificial, Respiratory Insufficiency

Keywords

Respiratory Insufficiency, Respiration, Artificial, Remifentanil, Respiratory Mechanics, Work of Breathing

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.

Interventions

DRUGremifentanil

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

DRUGplacebo

NaCl 0.9 %

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
pressure-time product	before and after remifentanil infusion; before and after placebo infusion.
respiratory rate/tidal volume	before and after remifentanil infusion; before and after placebo infusion.

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026