Effects of Remifentanil on Respiratory Function in Mechanically Ventilated Patients

Fondazione Poliambulanza Istituto Ospedaliero

Status and phase: Completed; Phase 4

Conditions: Conscious Sedation; Respiration, Artificial; Respiratory Insufficiency

Treatments: Drug: remifentanil; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00665119

FP-TIP-01

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 1 patient group

treatment

Experimental group

Description:

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.

Treatment:

Drug: placebo

Drug: remifentanil