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

NCT ID: NCT01195103

Last Updated: 2012-06-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Procedural Sedation Regional Anesthesia Block Orthopedic Surgery

Keywords

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Procedural sedation Regional Anesthesia block Orthopedic surgery Lusedra Fospropofol disodium Midazolam

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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10 mg/kg Lusedra

10 mg/kg Lusedra initial bolus.

Group Type EXPERIMENTAL

Fospropofol disodium

Intervention Type DRUG

10 mg/kg bolus

Fentanyl

Intervention Type DRUG

All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.

6.5 mg/kg Lusedra

6.5 mg/kg Lusedra initial bolus.

Group Type ACTIVE_COMPARATOR

Fospropofol disodium

Intervention Type DRUG

6.5 mg/kg bolus

Fentanyl

Intervention Type DRUG

All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.

Placebo + Midazolam

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

Group Type ACTIVE_COMPARATOR

Placebo + Midazolam

Intervention Type DRUG

Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients \<60 kg; 1.5 mg for patients ≥60 kg to \<90 kg; or 2 mg for patients ≥90 kg

Fentanyl

Intervention Type DRUG

All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.

Interventions

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Fospropofol disodium

10 mg/kg bolus

Intervention Type DRUG

Fospropofol disodium

6.5 mg/kg bolus

Intervention Type DRUG

Placebo + Midazolam

Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients \<60 kg; 1.5 mg for patients ≥60 kg to \<90 kg; or 2 mg for patients ≥90 kg

Intervention Type DRUG

Fentanyl

All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients \<60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.

Intervention Type DRUG

Other Intervention Names

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Lusedra Lusedra Versed Fentanyl Citrate Sublimaze

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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John B Leslie, MD MBA

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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10-000721

Identifier Type: -

Identifier Source: org_study_id