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

This study has been terminated.
Sponsor:
Collaborators:
PPD
Covance
Quest Pharmaceutical Services (Analytical Laboratory)
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00209599
First received: September 13, 2005
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Colonoscopy
Colon Polyps
Drug: fospropofol disodium
Phase 2

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 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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
  • 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 medication and Fully Alert, inclusive
  • Duration of sedation
  • Number of doses of study medication administered for the procedure
  • Time to sedation
  • Time that splenic flexure, hepatic flexure, and cecum are reached, and time to end of procedure
  • Number of repositionings
  • ·Number of procedure interruptions due to inadequate sedation
  • Patient-reported outcome and Investigator's assessment
  • Patient's rating of experience after Fully Recovered (including patient's level of sedation, memory recall, pain/discomfort, and willingness to be treated again);
  • Patient's rating at 24-hour telephone survey (including time to normal food intake and time to resuming normal activities)
  • Investigator's rating at the end of the procedure (including patient's level of sedation, pain/discomfort, anxiety, response to instructions, overall satisfaction with the study drug, and willingness to be use sedatives again)
  • Blinded evaluator's rating after Fully Recovered
  • Safety Variables
  • The following were safety endpoints:
  • Nature, frequency, severity, relationship to treatment, and outcome of all treatment emergent AEs (TEAEs)
  • Airway management (manual repositioning, increased oxygen flow, verbal or tactile stimulation)
  • Airway intervention (suction, manual ventilation, endotracheal intubation or other mechanical airway management)
  • Sedation-related AEs (hypopnea, apnea, hypoxemia, bradycardia, hypotension,)
  • Alternative sedation/hypnotic medications

Estimated Enrollment: 100
Study Start Date: February 2005
Study Completion Date: March 2005
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 elderly patients undergoing colonoscopy.

Following completion of preprocedure sedation assessments, patients will be randomly assigned to 1 of the 2 i.v. treatment groups at a 4:1 (AQUAVAN®. Injection: midazolam HCl) allocation ratio. To ensure that a distribution of ages is obtained, enrollment will be stratified into 2 equal-size groups by age (>65 to <72 years of age and >72 years of age). Randomization will be stratified by site within each age group. All patients 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 the depth of sedation provided met the goals of sedation, reduction of anxiety and reduced awareness.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209599

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

No publications provided

ClinicalTrials.gov Identifier: NCT00209599     History of Changes
Other Study ID Numbers: 3000-0415
Study First Received: September 13, 2005
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Colonoscopy
Seadation

Additional relevant MeSH terms:
Midazolam
Fospropofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014