A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures
Condition: Arthroscopy; Bunionectomy; Osteotomy; Carpal Tunnel
MeSH terms: Carpal Tunnel Syndrome
Intervention: fospropofol disodium
Intervention MeSH terms: Fospropofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AQUAVAN® Injection; Midazolam; Minor surgical procedures; Sedation

Summary:

      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.
    

Eligibility 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).