A Phase II, Randomized, Open-Label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Colonoscopy Procedures

3000-0415

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

2005-02-01

2005-03-01

Terminated

Early phase I

100

Inclusion Criteria: 1. Patient provided a signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study. 2. Patient was over 65 years of age at the time of screening. 3. Patient met 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 had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations. 5. Patient was unwilling to adhere to pre- and postprocedural instructions. 6. The use of fentanyl or midazolam was contraindicated for the patient. 7. Patient had participated in an investigational drug study within 1 month prior to study start. 8. Patient had prior exposure to AQUAVAN.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100}}

2023-06-18