Status:
TERMINATED
A Study of AQUAVAN® Injection for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
PPD Development, LP
Covance
Conditions:
Flexible Bronchoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a randomized, open-label study designed to assess the safety and efficacy of AQUAVAN® Injection versus midazolam HCl following pretreatment with an analgesic, fentanyl citrate injection, in pr...
Eligibility Criteria
Inclusion
- 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.
- 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 of I to III.
Exclusion
- 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 required artificial ventilation prior to the initiation of bronchoscopy or was admitted to the intensive care unit.
- 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 participated in an investigational study within 1 month prior to study start.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00209586
Start Date
September 1 2004
End Date
March 1 2005
Last Update
June 15 2023
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