Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209586
Status:
TERMINATED
Last Update Posted:
2023-06-15
First Post:
2005-09-13
Brief Title:
A Study of AQUAVAN Injection for Sedation in Elderly Patients Undergoing Flexible Bronchoscopy
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 Flexible Bronchoscopy Procedures
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patient enrollment was stopped prior to completion of the study in order to re-evaluate the dosing regimen
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients vital signs and depth of sedation After the procedure the patient physician and an evaluator are asked to complete satisfaction surveys
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 iv treatment groups at a 31 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 andor 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 Observers Assessment of Alertness Sedation OAAS 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 OAAS score is 2 or less or if there is no purposeful response to stimulation The depth of sedation will be measured by the Modified OAAS 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
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 andor 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 Observers Assessment of Alertness Sedation OAAS 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 OAAS score is 2 or less or if there is no purposeful response to stimulation The depth of sedation will be measured by the Modified OAAS 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
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