Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 0.5 mg/kg 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 sedative/hypnotic 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 sedative/hypnotic 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00209521
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 2
Start date June 2002
Completion date July 2003

See also
  Status Clinical Trial Phase
Recruiting NCT05139108 - TEE Monitoring and the Incidence of Postoperative Acute Kidney Injury in Coronary Artery Bypass Grafting
Recruiting NCT04523064 - iSGLT2 in Prevention of Acute Kidney Injury in Patients With Diabetes Mellitus Undergoing CABG Extracorporeal On-Pump Phase 4
Not yet recruiting NCT05540249 - Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG N/A
Completed NCT01467232 - IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting Phase 2
Completed NCT04631809 - Computed Tomography Coronary Angiography in Patients With a Previous Coronary Artery Bypass Graft Surgery Trial N/A
Completed NCT00073580 - Angiomax in Patients With HIT/HITTS Type II Undergoing Off-Pump Coronary Artery Bypass Grafting (CABG) (CHOOSE) Phase 3
Terminated NCT03346278 - Text Message Intervention to Improve Cardiac Rehab Participation N/A
Completed NCT00303641 - Safety and Effectiveness of the Medtronic Resting Heart Bypass System in Heart Surgery Patients Phase 1
Completed NCT03823521 - Observational Study to Investigate the Effects of Training on the Administration of Cardioplexolâ„¢ Phase 3
Terminated NCT00789399 - A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis N/A
Completed NCT02592824 - Glutamate for Metabolic Intervention in Coronary Surgery II Phase 3
Not yet recruiting NCT05079724 - Acute Kidney Injury After Cardiac Surgery
Withdrawn NCT04379947 - Preoperative Use of Fractional Flow Reserve in CABG Use and Effectiveness of FFR-based CABG in Real-life Practice
Terminated NCT00858936 - Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery Phase 2
Recruiting NCT01386229 - A Comparison of Etomidate and Ketamine for Anesthesia Induction in Coronary Artery Bypass Graft Surgery Phase 4
Completed NCT00653042 - Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA Phase 2
Completed NCT00318227 - Randomized Trial of a Liberal Versus a Restrictive Transfusion Strategy in Elderly Cardiac Surgery Patients N/A
Completed NCT00372671 - Evaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation Participation Phase 3
Not yet recruiting NCT05396690 - Safety and Efficacy of Remimazolam in OPCAB Surgery N/A
Recruiting NCT05411445 - Study of Role of Blood Microvescicles and Exosomes in Patients With Graft Occlusion After Aortocoronary Bypass Surgery