A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy
|First Received Date ICMJE||September 13, 2005|
|Last Updated Date||November 6, 2008|
|Start Date ICMJE||February 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00209599 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: fospropofol disodium|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Completion Date||March 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||65 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00209599|
|Other Study ID Numbers ICMJE||3000-0415|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Eisai Inc.|
|Information Provided By||Eisai Inc.|
|Verification Date||November 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP