Trial Outcomes & Findings for Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery (NCT NCT01195103)

NCT ID: NCT01195103

Last Updated: 2012-06-29

Results Overview

Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: approximately 4 minutes after administration of first bolus of study drug
• Results posted on: 2012-06-29

Participant Flow

Patients were recruited from Mayo Clinic, Arizona from March 1 - 11, 2011.

Participant milestones

Measure	10 mg/kg Lusedra 10 mg/kg Lusedra initial bolus	6.5 mg/kg Lusedra 6.5 mg/kg Lusedra initial bolus	Placebo + Midazolam Placebo initial bolus with dose of midazolam based on patient's weight
Overall Study STARTED	6	2	5
Overall Study COMPLETED	5	2	5
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	10 mg/kg Lusedra 10 mg/kg Lusedra initial bolus	6.5 mg/kg Lusedra 6.5 mg/kg Lusedra initial bolus	Placebo + Midazolam Placebo initial bolus with dose of midazolam based on patient's weight
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

Lusedra (Fospropofol Disodium) for Minimal to Moderate Sedation for Regional Anesthesia Block Prior to Orthopedic Surgery

Baseline characteristics by cohort

Measure	10 mg/kg Lusedra n=6 Participants 10 mg/kg Lusedra initial bolus	6.5 mg/kg Lusedra n=2 Participants 6.5 mg/kg Lusedra initial bolus	Placebo + Midazolam n=5 Participants Placebo initial bolus with dose of midazolam based on patient's weight	Total n=13 Participants Total of all reporting groups
Age Continuous	73.2 years STANDARD_DEVIATION 7.0 • n=5 Participants	71.5 years STANDARD_DEVIATION 4.3 • n=7 Participants	72 years STANDARD_DEVIATION 12 • n=5 Participants	72.6 years STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: approximately 4 minutes after administration of first bolus of study drug

Percentage of patients achieving a Modified Observer's Assessment of Alertness/Sedation Scale score less than or equal to 4, and the block procedure initiated, within 4 minutes of the administration of the first bolus of study drug. The Modified Observer's Assessment of Alertness/Sedation Scale ranges from 0 (does not respond to deep stimulus) to 6 (agitated). The score of 4 equals "lethargic response to name spoken in normal tone."

Outcome measures

Measure	10 mg/kg Lusedra n=5 Participants 10 mg/kg Lusedra initial bolus	6.5 mg/kg Lusedra n=2 Participants 6.5 mg/kg Lusedra initial bolus	Placebo + Midazolam n=5 Participants Placebo initial bolus with dose of midazolam based on patient's weight
Percentage of Participants Achieving Sedation Within 4 Minutes	100 percentage of participants	50 percentage of participants	40 percentage of participants

Adverse Events

10 mg/kg Lusedra

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

6.5 mg/kg Lusedra

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo + Midazolam

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	10 mg/kg Lusedra n=5 participants at risk 10 mg/kg Lusedra initial bolus	6.5 mg/kg Lusedra n=2 participants at risk 6.5 mg/kg Lusedra initial bolus	Placebo + Midazolam n=5 participants at risk Placebo initial bolus with dose of midazolam based on patient's weight
Respiratory, thoracic and mediastinal disorders apnea	20.0% 1/5 • Number of events 1 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	0.00% 0/2 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	0.00% 0/5 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.

Other adverse events

Measure	10 mg/kg Lusedra n=5 participants at risk 10 mg/kg Lusedra initial bolus	6.5 mg/kg Lusedra n=2 participants at risk 6.5 mg/kg Lusedra initial bolus	Placebo + Midazolam n=5 participants at risk Placebo initial bolus with dose of midazolam based on patient's weight
Nervous system disorders deep sedation	100.0% 5/5 • Number of events 5 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	0.00% 0/2 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	20.0% 1/5 • Number of events 1 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.
Nervous system disorders delayed recovery from sedation	40.0% 2/5 • Number of events 2 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	0.00% 0/2 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	40.0% 2/5 • Number of events 2 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.
Skin and subcutaneous tissue disorders puritis	60.0% 3/5 • Number of events 3 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	50.0% 1/2 • Number of events 1 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.	0.00% 0/5 • Patients were followed for adverse events from the time of drug administration until entry into the operating room. Patients were sedated again for the surgery. We only studied the first sedation. No adverse event data were collected for the patient who withdrew prior to receiving study drug, so that patient was not included in the assessment of adverse events.

Additional Information

John B Leslie MD

Mayo Clinic

Phone: 480-301-8000

Email: leslie.john@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place