Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125424
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2005-07-27
Brief Title:
Study of AQUAVAN Injection AQUAVAN Fospropofol Disodium for Sedation During Colonoscopy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Randomized Double-Blind Dose-Response Study to Assess the Efficacy and Safety of AQUAVAN Injection for Procedural Sedation in Patients Undergoing Colonoscopy
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:
Very often patients receive sedative medication before a diagnostic therapeutic or surgical procedure to help them relax keep them calm and to relieve them from pain This is called procedural sedation During procedural mild to moderate sedation a patient is first given a pain-relief medication analgesic and then a medication to help himher relax and keep himher calm sedative Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation AQUAVAN fospropofol disodium is made as a slow release version of propofol allowing for fast sedation and possibly faster recovery and discharge
This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate procedural sedation
This study is intended to compare several different doses of AQUAVAN in patients having a colonoscopy in order to find the right dose that will get patients to a level of mild to moderate procedural sedation
Detailed Description:
This is a randomized double-blind study designed to evaluate the dose-response in the sedation success rate for 4 different initial bolus doses of AQUAVAN following pretreatment with an analgesic fentanyl in patients undergoing a colonoscopy A group of patients will receive midazolam as a reference therapy
Following completion of pre-procedure assessments patients will be randomly assigned to 1 of 5 IV treatment groups at an equal allocation ratio 25 patients per arm on the day of the scheduled procedure Randomization will be stratified by age and ASA status
AQUAVAN initial bolus dose 1 8 mgkg AQUAVAN initial bolus dose 2 65 mgkg AQUAVAN initial bolus dose 3 5 mgkg AQUAVAN initial bolus dose 4 2 mgkg Midazolam initial bolus dose 002 mgkg
A person skilled in airway management and authorized by the facility in which the colonoscopy is performed such as a respiratory therapist a study nurse or a clinician must be immediately available during the conduct of the study All patients will be placed on supplemental oxygen via nasal cannula 4 Lmin and a 12-lead electrocardiogram ECG pulse oximeter and blood pressure monitor prior to administration of study medication All patients will receive an injection of analgesic pretreatment followed by the administration of sedative medication as described below This protocol recognizes 2 distinct phases of sedation Sedation Initiation and Sedation Maintenance Assessments will be made to evaluate the patients for levels of sedation clinical benefit and adverse events as detailed in the protocol Blood samples will be collected for pharmacokinetic PK analysis also detailed in the protocol
Following completion of pre-procedure assessments patients will be randomly assigned to 1 of 5 IV treatment groups at an equal allocation ratio 25 patients per arm on the day of the scheduled procedure Randomization will be stratified by age and ASA status
AQUAVAN initial bolus dose 1 8 mgkg AQUAVAN initial bolus dose 2 65 mgkg AQUAVAN initial bolus dose 3 5 mgkg AQUAVAN initial bolus dose 4 2 mgkg Midazolam initial bolus dose 002 mgkg
A person skilled in airway management and authorized by the facility in which the colonoscopy is performed such as a respiratory therapist a study nurse or a clinician must be immediately available during the conduct of the study All patients will be placed on supplemental oxygen via nasal cannula 4 Lmin and a 12-lead electrocardiogram ECG pulse oximeter and blood pressure monitor prior to administration of study medication All patients will receive an injection of analgesic pretreatment followed by the administration of sedative medication as described below This protocol recognizes 2 distinct phases of sedation Sedation Initiation and Sedation Maintenance Assessments will be made to evaluate the patients for levels of sedation clinical benefit and adverse events as detailed in the protocol Blood samples will be collected for pharmacokinetic PK analysis also detailed in the protocol
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GPI 3000-0520 | None | None | None |