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

NCT00209586 | Terminated Phase 3

• 1 other identifier: 3000-0409
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Flexible Bronchoscopy

Keywords

Bronchoscopy; Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation success defined for a patient as 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 (20)

• Secondary Efficacy Endpoints

• Time to Fully Recovered from end of procedure

• Time to Fully Alert from end of procedure

• Change from baseline DSST score over time during recovery period

• Modified OAA/S scores over time during the dosing initiation, procedural, and recovery periods

Interventions

fospropofol disodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

fospropofol

Study Officials

• James Jones, MD, PharmD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 1, 2004
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: June 15, 2023

Record last verified: 2012-01