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A Study of AQUAVAN® Injection for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy
This study has been terminated.
( Patient enrollment was stopped prior to completion of the study in order to re-evaluate the dosing regimen. )

First Received on September 13, 2005.   Last Updated on January 31, 2012   History of Changes
Sponsor: Eisai Inc.
Collaborators: PPD Development (Study Conduct and Clinical Monitoring)
Covance
Quest Pharmaceutical Services (Analytical Laboratory)
Information provided by: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00209586
  Purpose

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.


Condition Intervention Phase
Flexible Bronchoscopy
 Drug: fospropofol disodium
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-label Study to Assess the Safety and Efficacy of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Flexible Bronchoscopy Procedures

Resource links provided by NLM:

Drug Information available for: GPI 15715
U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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
  • Duration and percent of time when a patient's Modified OAA/S score is at each level between the first dose of study medications and Fully Alert, inclusive
  • Duration of sedation
  • Number of doses of study medication administered for the procedure
  • Time to sedation
  • Number of procedure interruptions due to inadequate sedation
  • Patient's rating of experience after Fully Recovered
  • Patient's rating at 24 hour post-discharge telephone survey
  • Investigator's rating at end of procedure
  • Blinded evaluator's rating after patient is Fully Recovered
  • Safety Endpoints
  • Nature, frequency, severity, relationship to treatment, and outcome of all adverse events
  • Sedation-related adverse events and interventions
  • Laboratory parameters and vital signs
  • Airway assistance
  • Concomitant medications

Enrollment: 55
Study Start Date: September 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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 producing sedation in patients undergoing a flexible bronchoscopy procedure. Randomization will be stratified by site. Following completion of pre-procedure sedation assessments, patients will be randomly assigned to 1 of the 2 i.v. treatment groups at a 3:1 (AQUAVAN® Injection: midazolam HCl) allocation ratio.

All study patients, irrespective of treatment group assignment, will receive fentanyl citrate injection as an analgesic pretreatment. Supplemental doses of fentanyl citrate injection may be administered if the patient reports pain or if inadequate analgesia is present as demonstrated by increased heart rate and/or blood pressure in the presence of adequate sedation. At no time should fentanyl citrate injection be administered to increase sedation levels. AQUAVAN® Injection and midazolam HCl will be administered to induce a state of adequate sedation, defined as a Modified Observer's Assessment of Alertness / Sedation (OAA/S) score of 4 or less. Supplemental doses will be administered to increase depth or duration of sedation. Supplemental doses will not be administered if the Modified OAA/S score is 2 or less or if there is no purposeful response to stimulation. The depth of sedation will be measured by the Modified OAA/S scale, a validated measure. Patient and Investigator assessments will be used to confirm that the depth of sedation provided met the goals of sedation, reduction of anxiety and reduced awareness.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient provided signed/dated Informed Consent and HIPAA Authorization after receiving a full explanation of the extent and nature of the study.
  2. Patient was at least 18 years of age at the time of screening.
  3. 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.
  4. Patient met the American Society of Anesthesiologists (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 required artificial ventilation prior to the initiation of bronchoscopy or was admitted to the intensive care unit.
  5. Patient had a history of mental or visual impairment that would not permit successful measurement of cognitive evaluations.
  6. Patient was unwilling to adhere to pre- and postprocedural instructions.
  7. The use of fentanyl or midazolam was contraindicated for the patient.
  8. Patient had participated in an investigational study within 1 month prior to study start.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209586

Sponsors and Collaborators
Eisai Inc.
PPD Development (Study Conduct and Clinical Monitoring)
Covance
Quest Pharmaceutical Services (Analytical Laboratory)
Investigators
Study Director: James Jones, MD, PharmD Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209586     History of Changes
Other Study ID Numbers: 3000-0409
Study First Received: September 13, 2005
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Bronchoscopy
Sedation

Additional relevant MeSH terms:
Fospropofol disodium
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012



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