PMID- 18641105
OWN - NLM
STAT- MEDLINE
DCOM- 20090126
LR  - 20211020
IS  - 1931-3543 (Electronic)
IS  - 0012-3692 (Linking)
VI  - 135
IP  - 1
DP  - 2009 Jan
TI  - A phase 3, randomized, double-blind study to assess the efficacy and safety of 
      fospropofol disodium injection for moderate sedation in patients undergoing 
      flexible bronchoscopy.
PG  - 41-47
LID - S0012-3692(09)60065-9 [pii]
LID - 10.1378/chest.08-0623 [doi]
AB  - BACKGROUND: Fospropofol disodium is a water-soluble prodrug of propofol with 
      unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, 
      multicenter study evaluated the use of fospropofol in patients undergoing 
      flexible bronchoscopy. METHODS: Patients >or= 18 years of age were randomized 
      (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with 
      fentanyl, 50 microg. Supplemental doses of each were given per protocol. The 
      primary end point was sedation success, which was defined as follows: three 
      consecutive Modified Observer's Assessment of Alertness/Sedation scores of <or= 4 
      plus procedure completion without alternative sedative medication and/or 
      mechanical ventilation. Other end points included treatment success, 
      patient/physician satisfaction, and safety. RESULTS: Of 252 patients, 150 were 
      randomized to receive 6.5 mg/kg fospropofol; 102 were randomized to receive 2 
      mg/kg fospropofol. Sedation success rates were 88.7% and 27.5%, respectively (p < 
      0.0001). Treatment successes (91.3% vs 41.2%, respectively; p < 0.001), 
      willingness to be treated again (94.6% vs 78.2%, respectively; p < 0.001), and 
      absence of procedural recall (83.3% vs 55.4%, respectively; p < 0.001) were 
      significantly better with the administration of 6.5 mg/kg fospropofol. The median 
      time to full alertness was slightly longer for the 6.5 mg/kg dose (5.5 vs 3.0 
      min, respectively). The proportion of patients requiring supplemental therapy 
      with analgesics (16.7% vs 37.3%, respectively) and the use of alternative 
      sedative medications (8.0% vs 58.8%, respectively) were lower for patients in the 
      6.5 mg/kg dose group (all comparisons, p < 0.001). The most frequent adverse 
      events (AEs) were transient and self-limited paresthesias and pruritus of 
      mild-to-moderate severity. Hypoxemia (predominantly mild-to-moderate) was the 
      most common sedation-related AE, and occurred in 15.4% and 12.6% of patients, 
      respectively, in the 6.5 and 2 mg/kg fospropofol dose groups. CONCLUSIONS: 
      Fospropofol provided safe and effective sedation for patients undergoing flexible 
      bronchoscopy. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00306722.
FAU - Silvestri, Gerard A
AU  - Silvestri GA
AD  - Division of Pulmonary and Critical Care Medicine, Medical University of South 
      Carolina, Charleston, SC. Electronic address: silvestri@musc.edu.
FAU - Vincent, Brad D
AU  - Vincent BD
AD  - Division of Pulmonary and Critical Care Medicine, Medical University of South 
      Carolina, Charleston, SC.
FAU - Wahidi, Momen M
AU  - Wahidi MM
AD  - Duke University School of Medicine, Durham, NC.
FAU - Robinette, Emory
AU  - Robinette E
AD  - Pulmonary Research, Johnston Memorial Hospital, Abingdon, VA.
FAU - Hansbrough, James R
AU  - Hansbrough JR
AD  - Graves-Gilbert Clinic, Bowling Green, KY.
FAU - Downie, Gordon H
AU  - Downie GH
AD  - Brody School of Medicine, East Carolina University, Greenville, NC.
LA  - eng
SI  - ClinicalTrials.gov/NCT00306722
GR  - K24 CA120494/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20080718
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Hypnotics and Sedatives)
RN  - LZ257RZP7K (fospropofol)
RN  - YI7VU623SF (Propofol)
SB  - IM
EIN - Chest. 2010 Mar;137(3):744
CIN - Chest. 2009 Jan;135(1):4-6. PMID: 19136399
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - *Bronchoscopes
MH  - *Bronchoscopy
MH  - *Conscious Sedation
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hypnotics and Sedatives/*administration & dosage/adverse effects
MH  - Injections, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Propofol/administration & dosage/adverse effects/*analogs & derivatives
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2008/07/22 09:00
MHDA- 2009/01/27 09:00
CRDT- 2008/07/22 09:00
PHST- 2008/07/22 09:00 [pubmed]
PHST- 2009/01/27 09:00 [medline]
PHST- 2008/07/22 09:00 [entrez]
AID - S0012-3692(09)60065-9 [pii]
AID - 10.1378/chest.08-0623 [doi]
PST - ppublish
SO  - Chest. 2009 Jan;135(1):41-47. doi: 10.1378/chest.08-0623. Epub 2008 Jul 18.