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

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Orthopedic Surgery; Regional Anesthesia Block; Procedural Sedation

Treatments: Drug: Placebo + Midazolam; Drug: Fentanyl; Drug: Fospropofol disodium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01195103

10-000721

Details and patient eligibility

About

How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?

Full description

The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a superior recovery profile compared to midazolam when used as a rescue comparator. While this study will only enroll patients undergoing regional blocks prior to orthopedic surgery, the clinical utility and value of the larger initial intravenous dosing for Lusedra may be evident for many different monitored anesthesia care anesthetic management situations requiring rapid and effective onset of effects.

Enrollment: 13 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergoing elective orthopedic surgery
• With a regional block prior to surgery
• Able to consent and complete the assessments and procedures
• If female, must be surgically sterile, postmenopausal, or not pregnant or lactating and using an acceptable method of birth control for at least 1 month prior to surgery with a negative urine pregnancy test at screening
• American Society of Anesthesiologists Physical Classification System status category P1 to P4

Exclusion criteria

• History of allergic reaction or hypersensitivity to any anesthetic agent, opioid, or benzodiazepine
• Fentanyl citrate injection or midazolam hydrocholoride injection contraindicated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

13 participants in 3 patient groups

10 mg/kg Lusedra

Experimental group

Description:

10 mg/kg Lusedra initial bolus.

Treatment:

Drug: Fospropofol disodium

Drug: Fentanyl

Drug: Fospropofol disodium

6.5 mg/kg Lusedra

Active Comparator group

Description:

6.5 mg/kg Lusedra initial bolus.

Treatment:

Drug: Fospropofol disodium

Drug: Fentanyl

Drug: Fospropofol disodium

Placebo + Midazolam

Active Comparator group

Description:

Placebo initial bolus with dose of midazolam based on patient's weight

Treatment:

Drug: Fentanyl

Drug: Placebo + Midazolam