Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209547
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2005-09-13
Brief Title:
Study to Assess Safety and Efficacy of AQUAVAN Injection for Sedation During Cardiac Catheterization
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
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 Percutaneous Coronary PC Procedures
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The anticipation of pain and discomfort a diagnosis and other intrinsic unknowns make patients anxious both prior to and during a procedure Therefore the main goal of sedation with analgesia used during various diagnostic therapeutic or surgical procedures is to relieve this anxiety discomfort and pain which are all interrelated The optimal level of sedation for any given patient is one that allows the patient to tolerate the procedure and provides an appropriate safety margin This was a study designed to examine the safety and efficacy of AQUAVAN Injection versus a commonly used approved sedative drug midazolam HCl following pretreatment with fentanyl citrate injection for pain relief in producing sedation in patients undergoing single cardiac catheterization procedures
Detailed Description:
This was a randomized open-label study designed to assess the safety and efficacy of AQUAVAN Injection hereafter referred to as AQUAVAN versus the reference drug midazolam HCl hereafter referred to as midazolam following pretreatment with fentanyl citrate injection hereafter referred to as fentanyl in producing sedation in male and female patients undergoing single PC procedures
Screening assessments were done within 2 weeks of scheduled procedures After completion of preprocedural sedation assessments patients were randomly assigned to 1 of the 2 treatment groups at a 31 AQUAVAN midazolam allocation ratio on the day of the scheduled procedure Day 0 via an Interactive Voice Response System IVRS Randomization was stratified by site
All patients regardless of treatment group assignment received fentanyl as an analgesic pretreatment Supplemental doses of fentanyl could be administered if the patient reported pain or if analgesia was inadequate as demonstrated by increased heart rate andor blood pressure in the presence of adequate sedation At no time was fentanyl to be administered to increase sedation levels
AQUAVAN or midazolam was administered by intravenous iv bolus to induce a state of minimal-to-moderate procedural s sedation defined as a score of 4 on the Modified Observers Assessment of AlertnessSedation OAAS scale Supplemental doses were administered if necessary to increase the depth or duration of sedation Supplemental doses were not administered if the Modified OAAS score was 2 or if there was no purposeful response to stimulation Patient and Investigator assessments were used to confirm that the depth of sedation met the goals of sedation reduced anxiety and awareness
Follow-up patient assessments were conducted in a telephone interview 24 hours following treatment and during a clinic visit 2 to 5 days following treatment
Screening assessments were done within 2 weeks of scheduled procedures After completion of preprocedural sedation assessments patients were randomly assigned to 1 of the 2 treatment groups at a 31 AQUAVAN midazolam allocation ratio on the day of the scheduled procedure Day 0 via an Interactive Voice Response System IVRS Randomization was stratified by site
All patients regardless of treatment group assignment received fentanyl as an analgesic pretreatment Supplemental doses of fentanyl could be administered if the patient reported pain or if analgesia was inadequate as demonstrated by increased heart rate andor blood pressure in the presence of adequate sedation At no time was fentanyl to be administered to increase sedation levels
AQUAVAN or midazolam was administered by intravenous iv bolus to induce a state of minimal-to-moderate procedural s sedation defined as a score of 4 on the Modified Observers Assessment of AlertnessSedation OAAS scale Supplemental doses were administered if necessary to increase the depth or duration of sedation Supplemental doses were not administered if the Modified OAAS score was 2 or if there was no purposeful response to stimulation Patient and Investigator assessments were used to confirm that the depth of sedation met the goals of sedation reduced anxiety and awareness
Follow-up patient assessments were conducted in a telephone interview 24 hours following treatment and during a clinic visit 2 to 5 days following treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None