Totally Transdermal Sedation in the Weaning From Remifentanil Infusion

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 15, 2021

Primary Completion Date

April 6, 2024

Study Completion Date

April 6, 2024

Conditions
Respiratory InsufficiencyVentilator WeaningAnalgesics, Opioid
Interventions
DRUG

Fentanyl Transdermal System

in the experimental arm transdermal fentanyl will be administered with a starting dose of 50 mcg/hr simultaneously with the preexistent remifentanil continue infusion. Remifentanil infusion rate will be increased or decreased based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit. After randomization, the transdermal fentanyl dose can be modified every 24 hours according to the study protocol to achieve the desired effect in terms of PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected

DRUG

Remifentanil

"In the active comparator arm remifentanil infusion is administered alone, the infusion rate will be increased or decreased according to the study protocol based on PaCO2 value resulting from the Arterial Blood Gases sample (ABG) collected at each visit.~In the experimental arm remifentanil is use together with transdermal fentanyl"

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT04204967 - Totally Transdermal Sedation in the Weaning From Remifentanil Infusion | Biotech Hunter | Biotech Hunter