Remifentanil versus fentanyl for analgesia-based sedation to provide patient comfort in the intensive care unit

GlaxoSmithKline (UK)0 sites152 target enrollmentOctober 22, 2003

Overview

No summary available.

Registry

who.int

Start Date

October 22, 2003

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

GlaxoSmithKline (UK)

•A subject will be eligible for inclusion in this study only if all of the following criteria apply:
•1\. Admitted into the ICU within the previous 24 hours
•2\. Intubated and expected to require short\-term mechanical ventilation (i.e. for at least a further 12 hours and up to 72 hours after starting the study drug infusion)
•3\. Aged over 18 years old
•4\. A female is eligible to enter and participate in this study if she is of:
•4\.1\. Non\-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post\-menopausal) or,
•4\.2\. Child\-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following:
•4\.2\.1\. Complete abstinence from intercourse from two weeks prior to administration of study drug, throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug (minimum of 7 days)
•4\.2\.2\. Female sterilisation
•4\.2\.3\. Sterilisation of male partner

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1\. Concurrent medications:
•1\.1\. Requires neuromuscular blocking agents to facilitate mechanical ventilation
•1\.2\. Has or is likely to receive an epidural block during the maintenance phase
•2\. The use of remifentanil, fentanyl or propofol is contraindicated
•3\. Concurrent disease or disorder:
•3\.1\. Has or is likely to require a tracheostomy within 96 hours after admission to the ICU
•3\.2\. Has a neurological disease or other medical condition that may affect the ability to assess the SAS score and PI (e.g. stroke, stupor or coma, dementia)
•3\.3\. Predicted creatinine clearance of \<50 mL/min indicating moderate or severe renal impairment
•3\.4\. Modified ICU admission simplified acute physiology score (SAPS) II score of greater than 43