A Study of AQUAVAN® Injection for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing flexible bronchoscopy as well as to assess the safety profile of AQUAVAN versus that of midazolam. Prior to the procedure, patients receive fentanyl citrate for pain management followed five minutes later by either AQUAVAN® Injection or midazolam HCl for sedation. During the procedure, study personnel assess the patient's vital signs and depth of sedation. After the procedure, the patient, physician, and an evaluator are asked to complete satisfaction surveys.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Collaborators: Covance; PPD; Quest Pharmaceutical Services
• Treatments: Fospropofol

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.

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 of I to III.

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 required artificial ventilation prior to the initiation of bronchoscopy or was admitted to the intensive care unit.

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 participated in an investigational study within 1 month prior to study start.