Document Detail

A randomized, open-label study of the safety and tolerability of fospropofol for patients requiring intubation and mechanical ventilation in the intensive care unit.
MedLine Citation:
PMID:  21596879     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Current drugs for induction and maintenance of sedation in mechanically ventilated patients in the intensive care unit have limitations. Fospropofol, a prodrug of propofol, has not been studied as a sedative in the ICU setting.
METHODS: In this randomized, open-label pilot study, patients received 1 of 3 regimens with a goal of maintaining a Ramsay Sedation Score of 2 to 5: (1) fospropofol IV infusion with a bolus and increased infusion rate for agitation events (infusion/bolus); (2) fospropofol IV infusion with an increased infusion rate for agitation events (infusion only); or (3) propofol IV infusion with an increased infusion rate for agitation events.
RESULTS: Sixty patients received study drug and were included in the safety and efficacy analyses. Because incidence rates for adverse events were similar between fospropofol groups, and because the study was not powered to determine significant differences between treatment groups for safety variables, adverse events for both fospropofol groups were combined. In the fospropofol groups, 28 out of 38 patients (74%) experienced treatment-emergent adverse events in comparison with 14 out of 22 patients (64%) in the propofol group. The most common treatment-emergent adverse events with fospropofol were procedural pain (21.1%) and nausea (13.2%). Two patients (1 each in the fospropofol infusion/bolus and the propofol groups) experienced hypotension during the study as a potential sedation-related adverse event. Mean plasma formate levels were not significantly different among groups. Patients in all 3 treatment groups maintained Ramsay Sedation Scores of 2 to 5 for >90% of the time they were sedated.
CONCLUSION: This pilot study suggests that fospropofol, administered in either an infusion/bolus or infusion-only regimen, is tolerable and effective for short-term induction and maintenance of sedation in mechanically ventilated intensive care unit patients.
Keith A Candiotti; Tong J Gan; Christopher Young; Alex Bekker; S T John Sum-Ping; Richard Kahn; Philip Lebowitz; Jeffrey J Littman
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2011-05-19
Journal Detail:
Title:  Anesthesia and analgesia     Volume:  113     ISSN:  1526-7598     ISO Abbreviation:  Anesth. Analg.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-08-24     Completed Date:  2011-10-14     Revised Date:  2013-04-16    
Medline Journal Info:
Nlm Unique ID:  1310650     Medline TA:  Anesth Analg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  550-6     Citation Subset:  AIM; IM    
Department of Anesthesiology, University of Miami/Jackson Memorial Hospital, R-C370, 1611 NW 12th Avenue, Miami, FL 33101, USA.
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MeSH Terms
Aged, 80 and over
Drug Administration Schedule
Hypnotics and Sedatives / administration & dosage*,  adverse effects
Infusions, Intravenous
Injections, Intravenous
Intensive Care*
Intensive Care Units
Intubation, Intratracheal*
Middle Aged
Pilot Projects
Propofol / administration & dosage,  adverse effects,  analogs & derivatives*
Respiration, Artificial*
Time Factors
Treatment Outcome
United States
Young Adult
Reg. No./Substance:
0/Hypnotics and Sedatives; 2078-54-8/Propofol; LZ257RZP7K/fospropofol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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