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

NCT00209599 | Terminated Phase 2

• 1 other identifier: 3000-0415
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Colonoscopy; Colon Polyps

Keywords

Colonoscopy; Seadation

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was Sedation Success defined as a patient having 3 consecutive Modified OAA/S scores ≤4 and completing the procedure without requiring alternative sedative medications and without requiring manual or mechanical ventilation.

Secondary Outcomes (25)

• Measures of recovery and cognitive functions by the blinded evaluator

• Time to Fully Recovered from the end of the procedure

• Time to Fully Alert from the end of the procedure

• Change from baseline DSST score over time during the Recovery period

• Measures of sedation adequacy

Interventions

fospropofol disodium DRUG

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient provided a signed/dated Informed Consent and HIPAA authorization after receiving a full explanation of the extent and nature of the study.
• Patient was over 65 years of age at the time of screening.
• Patient met ASA Physical Status Classification of I to III.

You may not qualify if:

• 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 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 drug study within 1 month prior to study start.
• Patient had prior exposure to AQUAVAN.

Sponsors & Collaborators

• Eisai Inc.: lead
• PPD Development, LP: collaborator
• Covance: collaborator
• Quest Pharmaceutical Services: collaborator

MeSH Terms

Conditions

Colonic Polyps

Interventions

fospropofol

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• James Jones, MD,PharmD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2005
• Study Completion: March 1, 2005
• Last Updated: June 18, 2023

Record last verified: 2008-11