A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to demonstrate that AQUAVAN® is effective in providing adequate sedation in patients undergoing 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.

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

Details

• Lead Sponsor: Eisai Inc.
• Collaborators: Bio Analytical Research Corporation; Coghlan Group (Plasma Sample Supplies); MDS Pharma Services; PPD
• Treatments: Fospropofol; Midazolam

Criteria

Inclusion Criteria:

• Patient provided a signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study;

• Patient, if female, were surgically sterile, postmenopausal or non-pregnant and non lactating 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 predose periods; and

• Patient met American Society of Anesthesiologists (ASA) Physical Status Classification System of I to III.

Exclusion Criteria:

• 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 participated in an investigational drug study within 1 month prior to study start;

• 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; or

• Patient for whom the use of fentanyl or midazolam was contraindicated.