The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia
This is a multicenter, randomized, controlled, observer-blinded, dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery with general anesthesia.
Gantacurium chloride for injection (previously referred to as AV430A) is a new, investigational non-depolarizing ultra-short acting neuromuscular blocking agent (NMB). Preliminary results in animals and healthy human subjects (Phase 1 studies in adult volunteers) suggest that gantacurium chloride for injection may provide a useful adjunct to general anesthesia by permitting rapid intubation. This Phase 2 study will provide more definitive information on the ultra-short acting profile of the compound by determining the quality of intubation in patients, at 60 seconds, as assessed by a blinded intubator. In addition, the safety of the compound will be assessed. In this study, the efficacy and safety of gantacurium chloride for injection will also be compared to a reference drug, succinylcholine, and to placebo.
The primary objective of this study is to determine the dose-response relationship of gantacurium chloride for injection on tracheal intubation conditions after a single rapid bolus intravenous (i.v.) dose as a component of a propofol/opioid induction-intubation sequence and to assess the safety profile of this compound.
Drug: Gantacurium Chloride for Injection (AV430A)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Controlled, Observer-Blinded, Dose-Response Study to Evaluate the Efficacy in Tracheal Intubation and Safety of Gantacurium Chloride for Injection in Healthy Adult Patients Undergoing Surgery With General Anesthesia|
- The primary endpoint in this study is the graded intubation scores at 60 seconds after administration of single rapid i.v. bolus doses of study treatments (gantacurium chloride for injection, succinylcholine, or placebo)
- Graded intubation scores at 120 seconds after administration of single rapid i.v. bolus doses of study treatments for those patients in whom the first intubation attempt at 60 seconds failed
- Blood pressure (BP) and heart rate (HR) measurements beginning with a propofol/opioid induction-intubation sequence and ending 10 minutes after the initial intubation attempt
- 12-lead electrocardiograph (ECG) measurements
- Number and frequency of adverse events (AEs)
- Clinical laboratory data
- Vital sign measurements
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||March 2006|
|Technischen Universitat Munchen|
|Principal Investigator:||Manfred Blobner, MD||Technischen Universitat Munchen|
|Principal Investigator:||Jorgen Viby-Mogensen, MD||Academic Department of Anasthesia and Intensive Care|