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

This study has been terminated.
Sponsor:
Collaborators:
PPD
Covance
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00209560
First received: September 13, 2005
Last updated: July 11, 2014
Last verified: July 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Successful Sedation of Subjects, Defined for a Subject as Having 3 Consecutive Scores ≤ 4 on the Modified Observer's Assessment of Alertness/Sedation Scale and Completing the Procedure w/o Alternative Sedative Medications/w/o Manual/Mechanical Ventilation [ Time Frame: Sedation success was assessed at 2 minute intervals until the end of the procedure ] [ Designated as safety issue: No ]

    The Modified OAA/S (MOAA/S) scale is based on a validated, 6-point rating scale. Scores are not combined.

    Score 5 (alert) -- responds readily to name spoken in normal tone Score 4 -- Lethargic response to name spoken in normal tone Score 3 -- Responds only after name is called loudly and/or repeatedly Score 2 -- Responds only after mild prodding or shaking Score 1 -- Responds only after painful trapezius squeeze Score 0 -- Does not respond to painful trapezius squeeze



Secondary Outcome Measures:
  • Time to Fully Alert From the End of the Procedure [ Time Frame: At 2-minute intervals from the end of the procedure until the subject met the criteria for Fully Alert status ] [ Designated as safety issue: No ]
    Time to Fully Alert, defined as the time to the first of 3 consecutive Modified OAA/S scores of 5 from the end of the surgical procedure, was summarized.


Enrollment: 168
Study Start Date: October 2004
Estimated Study Completion Date: March 2005
Detailed Description:

Randomized, open label, multi-center,midazolam 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.

Midazolam is the most widely used i.v. agent for minimal-to-moderate sedation. The dose range of midazolam to induce minimal to moderate sedation was based on standard clinical practice.

[new paragraph] All patients were pre-medicated with fentanyl citrate as an analgesic.

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:

  1. Patient provided signed/dated Informed Consent and HIPAA Authorization after receiving a full explanation of the extent and nature of the study.
  2. 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.)
  3. 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.
  4. Patient met the American Society of Anesthesiologists (ASA) Physical Status Classification System of I to III.
  5. Patient may have been an inpatient or outpatient scheduled to undergo a single minor surgical and/or therapeutic procedure.

Exclusion Criteria:

  1. Patient had a history of allergic reaction or hypersensitivity to any anesthetic agent, narcotic, or benzodiazepine.
  2. Patient did not meet nils per os (NPO) status per ASA Guideline or institution's guideline.
  3. Patient had condition(s) that, in the opinion of the Investigator, could interfere with appropriate airway management.
  4. Patient had participated in an investigational drug study within 1 month prior to study start.
  5. Patient had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
  6. Patient was unwilling to adhere to pre- and postprocedural instructions.
  7. The use of fentanyl or midazolam was contraindicated for the patient.
  8. Patient had experienced multiple concurrent injuries or trauma.
  9. Patient was scheduled to undergo multiple same-day procedures (eg, bunionectomies on both feet).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Inc.
  More Information

No publications provided

Responsible Party: Eisai Medical Services, Eisai Inc.
ClinicalTrials.gov Identifier: NCT00209560     History of Changes
Other Study ID Numbers: 3000-0412
Study First Received: September 13, 2005
Results First Received: March 1, 2012
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
AQUAVAN® Injection
Midazolam
Minor surgical procedures
Sedation

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Fospropofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014