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.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Product Name: Gantacurium for Injection Product Code: AV430A Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Gantacurium Chloride Current Sponsor code: AV430A Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use Product Name: Succinylcholine Pharmaceutical Form: Solution for injection INN or Proposed INN: Suxamethonium Chloride CAS Number: 306‐40‐1 Other descriptive name: Succinylcholine Chloride Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ CONDITION: Adjunct to anesthesia to facilitate tracheal intubation (non‐depolarizing neuromuscular blocking agent) PRIMARY OUTCOME: Main Objective: Gantacurium Chloride for Injection on tracheal intubation conditions at 60 seconds after administration of a single rapid bolus i.v. The primary objective of this study is to determine the dose‐response relationship of dose as a component of a propofol/opioid induction‐intubation sequence. Primary end point(s): 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) Secondary Objective: Secondary objectives of this study are as follows:; 1. To describe the tracheal intubation conditions at 60 seconds after administration of Gantacurium Chloride for Injection with those produced by succinylcholine and placebo; ; 2. To describe the cardiovascular (blood pressure [BP], heart rate [HR], and cardiac rhythm) and general safety profile of a range of single rapid bolus i.v. doses of Gantacurium Chloride for Injection when administered as a component of a propofol/opioid induction‐intubation sequence in surgical patients; ; 3. To compare the safety profile of Gantacurium Chloride for Injection with those of succinylcholine and placebo; ; 4. To determine the minimum effective dose of Gantacurium Chloride for Injection that provides acceptable intubating conditions in =85% of subjects. INCLUSION CRITERIA: A patient will be eligible for inclusion in this study only if all of the following criteria are met: 1. Male or female between 18 and 65 years of age scheduled for low‐ or moderate‐risk surgical procedure requiring tracheal intubation 2. Female patients must not be of child‐bearing potential. Females must meet one of the following criteria: • Be postmenopausal; • Have undergone prior tubal ligation or hysterectomy; or • Be scheduled for hysterectomy as the surgical procedure for this study 3. ASA Physical Status Classification 1 or 2 ( refer to Appendix C) 4. Weight within 30% of ideal body weight (refer to Appendix D) 5. Able to read and to comprehend information about the study design and procedure; willingness to participate in this study as evidenced by a signed and dated written Informed Consent Form 6. In good physical and mental health as determined by the following procedures/evaluations (completed within 14 days prio
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First added on: Aug 21, 2024