A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures - Full Text View

Sponsors and Collaborators:	Eisai Inc. PPD Covance
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00209560

Purpose

The purpose of this study is to determine the safety, tolerability, and efficacy of AQUAVAN® Injection when used for mild-to-moderate sedation in patients undergoing minor surgical procedures.

Condition	Intervention	Phase
Arthroscopy Bunionectomy Osteotomy Carpal Tunnel	Drug: fospropofol disodium	Phase III

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome Surgery

Drug Information available for: Midazolam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Minor Surgical Procedures

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

The primary efficacy objective was to demonstrate that AQUAVAN® Injection was effective in providing adequate sedation in patients undergoing minor surgical and/or therapeutic procedures in patients premedicated with fentanyl citrate.

Secondary Outcome Measures:

Measures of recovery and cognitive functions by the blinded evaluator.
Measures of sedation adequacy.
Patient-reported outcome and Investigator's assessment.
Patient's rating of his/her experience after Fully Recovered.
Patient's rating at telephone survey.
Investigator's rating at the end of the procedure.
Nature, frequency, severity, relationship to treatment, and outcome of all treatment emergent adverse events (TEAEs).
Airway assistance.
Sedation-related adverse events (SRAEs).
Laboratory parameters and vital signs.
Concomitant medications.
Alternative sedation/hypnotic medications.

Estimated Enrollment:	240
Study Start Date:	November 2004
Estimated Study Completion Date:	March 2005

Detailed Description:

Randomized, open label, multi-center, adaptive dose ranging study, in which several dose levels of AQUAVAN® Injection and fentanyl citrate injection will be investigated to produce a desired sedation level in patients undergoing minor surgical and/or therapeutic procedures. A desired sedative dose/dose range and dosing paradigm will be identified based on pre-set criteria using the Modified Observer's Assessment of Alertness/Sedation (OAA/S). The desired sedative dose/dose range and dosing paradigm of AQUAVAN® Injection is defined as one that consistently provides mild to moderate sedation (Modified OAA/S between 2 and 4 inclusive) in majority of patients who are pre-medicated with fentanyl citrate injection.

The outpatient setting has become increasingly popular for various types of medical procedures requiring sedation. In outpatient minor surgical procedures, sedation agents are used to provide mild-to-moderate sedation and are used with other medicines for pain management. Surgeons have searched for alternative treatments to use in the outpatient setting that would provide a faster recovery time with minimal post-procedure amnesia. This injection is used following pretreatment with fentanyl citrate for pain management.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient provided signed/dated Informed Consent and HIPAA Authorization after receiving a full explanation of the extent and nature of the study.
Patient was at least 18 years of age at the time of screening. (Prior to Amendment 1, dated 03 February 2005, this criterion restricted enrollment to patients who were ≥18 and ≤65 years of age. To ensure that safe dosing levels were administered to patients >65 years of age, AQUAVAN and midazolam dosing levels were reduced when compared with patients between 18 and 65 years of age, inclusive. The majority of patients were enrolled prior to 03 February 2005.)
Female patient must have been surgically sterile, postmenopausal, or not pregnant or lactating, and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predosing periods.
Patient met the American Society of Anesthesiologists (ASA) Physical Status Classification System of I to III.
Patient may have been an inpatient or outpatient scheduled to undergo a single minor surgical and/or therapeutic procedure.

Exclusion Criteria:

Patient had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
Patient had condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.
Patient had participated in an investigational drug study within 1 month prior to study start.
Patient had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
Patient was unwilling to adhere to pre- and postprocedural instructions.
The use of fentanyl or midazolam was contraindicated for the patient.
Patient had experienced multiple concurrent injuries or trauma.
Patient was scheduled to undergo multiple same-day procedures (eg, bunionectomies on both feet).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209560

Sponsors and Collaborators

Eisai Inc.

PPD

Covance

Investigators

Study Director:

James Jones, MD, PharmD

Eisai Medical Research Inc.

More Information

No publications provided

Responsible Party:	Eisai Inc. ( Eisai Medical Services )
Study ID Numbers:	3000-0412
Study First Received:	September 13, 2005
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00209560 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Medical Research Inc.:

AQUAVAN® Injection
Midazolam
Minor surgical procedures
Sedation

Study placed in the following topic categories:

Roussy Levy Hereditary Areflexic Dystasia
Carpal Tunnel Syndrome
Charcot Marie Tooth Disease
Charcot-Marie-Tooth Disease
Wounds and Injuries
Disorders of Environmental Origin
Midazolam
Tomaculous Neuropathy

Mononeuropathies
Nerve Compression Syndromes
Neuromuscular Diseases
Peripheral Nervous System Diseases
Hereditary Motor and Sensory Neuropathies
Cumulative Trauma Disorders
Sprains and Strains

Additional relevant MeSH terms:

Nerve Compression Syndromes
Median Neuropathy
Carpal Tunnel Syndrome
Neuromuscular Diseases
Peripheral Nervous System Diseases
Nervous System Diseases

Wounds and Injuries
Disorders of Environmental Origin
Mononeuropathies
Sprains and Strains
Cumulative Trauma Disorders

ClinicalTrials.gov processed this record on May 07, 2009