Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00209521
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2005-09-13
Brief Title:
Comparison of AQUAVAN Injection to DISOPRIVAN Injectable Emulsion for Anesthesia During Coronary Artery Surgery
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
Phase 2 Randomized Study of AQUAVAN Injection In Elective Coronary Artery Surgery With Comparison to DISOPRIVAN Injectable Emulsion
Status:
COMPLETED
Status Verified Date:
2010-06
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 is an exploratory clinical trial designed to examine the efficacy safety and tolerability of fospropofol AQUAVAN Injection compared to propofol DISOPRIVAN Injectable Emulsion when used to preoperatively sedate induce and maintain general anesthesia and to postoperatively sedate patients undergoing elective coronary artery surgery
Detailed Description:
This Phase 2 open-label single-center randomized clinical trial was designed to examine the efficacy and tolerability of AQUAVAN Injection hereafter referred to as AQUAVAN when used to preoperatively sedate induce and maintain general anesthesia and to postoperatively sedate patients undergoing elective coronary artery surgery Eligible patients were randomized to either AQUAVAN or DISOPRIVAN Injectable Emulsion hereafter referred to as DISOPRIVAN following screening and prior to their arrival in the surgical suite
On the day of surgery after the administration a 05 mgkg bolus dose of lignocaine preoperative sedation began using the target-controlled infusion TCI system to target desired sedation plasma concentrations of either AQUAVAN or DISOPRIVAN depending on the randomization schedule
The Bispectral BIS Index was used to guide study drug administration target BIS ranges were 60 to 80 for sedation and 40 to 60 for the maintenance of anesthesia Adequate sedativehypnotic effect during surgical anesthesia was characterized by the portion of time within the target BIS Index range versus total surgical time Following this during postsurgical sedation inadequate sedativehypnotic effect was characterized by the number duration and magnitude of BIS scores outside of the target range versus total postsurgical sedation time During postsurgical sedation the Modified Ramsey Scale was used as an additional clinical tool to evaluate the state of sedation with an attempt to maintain the score between 3 and 5
The overall quality of induction maintenance and ease of control of anesthesia and quality of sedation before and during cardiopulmonary bypass CPB were each graded by the anesthesiologist
Continuous monitoring of blood pressure and heart rate were used to assess the hemodynamic effect of study drug Hypertension and hypotension were defined as excursions of 20 from the baseline value
On the day of surgery after the administration a 05 mgkg bolus dose of lignocaine preoperative sedation began using the target-controlled infusion TCI system to target desired sedation plasma concentrations of either AQUAVAN or DISOPRIVAN depending on the randomization schedule
The Bispectral BIS Index was used to guide study drug administration target BIS ranges were 60 to 80 for sedation and 40 to 60 for the maintenance of anesthesia Adequate sedativehypnotic effect during surgical anesthesia was characterized by the portion of time within the target BIS Index range versus total surgical time Following this during postsurgical sedation inadequate sedativehypnotic effect was characterized by the number duration and magnitude of BIS scores outside of the target range versus total postsurgical sedation time During postsurgical sedation the Modified Ramsey Scale was used as an additional clinical tool to evaluate the state of sedation with an attempt to maintain the score between 3 and 5
The overall quality of induction maintenance and ease of control of anesthesia and quality of sedation before and during cardiopulmonary bypass CPB were each graded by the anesthesiologist
Continuous monitoring of blood pressure and heart rate were used to assess the hemodynamic effect of study drug Hypertension and hypotension were defined as excursions of 20 from the baseline value
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