Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209599
Status:
TERMINATED
Last Update Posted:
2023-06-18
First Post:
2005-09-13
Brief Title:
A Study of AQUAVAN Injection Versus Midazolam HCl for Sedation in Elderly Patients Undergoing Elective Colonoscopy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 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 patients vital signs and depth of sedation After the procedure the patient physician and an evaluator were 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 elderly patients undergoing colonoscopy
Following completion of preprocedure sedation assessments patients will be randomly assigned to 1 of the 2 iv treatment groups at a 41 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 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 AlertnessSedation 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 the depth of sedation provided met the goals of sedation reduction of anxiety and reduced awareness
Following completion of preprocedure sedation assessments patients will be randomly assigned to 1 of the 2 iv treatment groups at a 41 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 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 AlertnessSedation 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 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