The purpose of this study is to evaluate the safety and efficacy of LUSEDRA (fospropofol disodium) and to determine whether a dose lower than currently approved can provide effective moderate sedation required to complete diagnostic or therapeutic procedures.
This will be a double-blind, randomized, parallel-group, multicenter, dose-ranging study, in age \>/= 65 years, and/or weight \< 60 kg, and/or American Society of Anesthesiologists (ASA) Physical Classification Status 3 or 4 subjects using either the approved dose modification or 1 lower dose, to achieve a moderate level of sedation required to complete the scheduled diagnostic or therapeutic procedure. Three subgroups of subjects will be included. For Subgroup 1 and Subgroup 2, approximately equal numbers of subjects will be enrolled into 2 strata: weight \>/= 55 kg and weight \< 55 kg. For Subgroup 1 and Subgroup 2, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio within each stratum. For Subgroup 3, subjects will be randomly assigned to 1 of 2 dose groups in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
153
Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight \< 60 kg and Age \< 65 years and ASAI and II)
(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight \<60 kg and Age \<65 years and ASAI and II)
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight \< 60 kg and Age \>/=65 years and ASA 3 or 4
Hope Research Institute
Phoenix, Arizona, United States
Number of Participants With Sedation Success
Sedation success was defined as subjects who met the following 4 criteria: had 3 consecutive Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the subject's level of responsiveness. A high score on the MOAA/S scale indicated a lower level of sedation.
Time frame: Day 1
Number of Participants With Treatment Success
Treatment success was defined as subjects who met the following 3 criteria: completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation.
Time frame: Day 1
Number of Participants With Modified Sedation Success
Modified sedation success was defined as a subject who was a sedation success and did not have a MOAA/S score \<2 any time after administration of sedative medication. Sedation success was defined as subjects who had 3 consecutive MOAA/S scores at or less than 4 after administration of sedative medication, completed the procedure, did not require the use of alternative sedative medication, and did not require manual/mechanical ventilation. The MOAA/S score was used to clinically rate the level of sedation using a score of 0 to 5 based on the level of responsiveness.
Time frame: Day 1
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(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight \<60 kg and Age \>/=65 years and ASA 3 or 4
(Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight \>/= 60 kg and Age \>/= 65 years and ASA 3 or 4
Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight \>/= 60 kg and Age \>/= 65 years and ASA 3 or 4
Southern California Permanente Medical Group
Baldwin Park, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Center for Advanced Gastroenterology
Maitland, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Sheridan Clinical Research
Sunrise, Florida, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States
Creighton University Medical Center
Omaha, Nebraska, United States
...and 13 more locations