Adjunct to anesthesia to facilitate tracheal intubation (non-depolarizing neuromuscular blocking agent)
Conditions
Interventions
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
C
Sponsors
Avera Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 prior to the Induction Phase [scheduled surgical procedure]): • A complete medical history • A complete physical examination • A standard 12-lead ECG and rhythm strip • Measurement of vital signs, including BP (supine), HR/pulse (supine), respiration rate and temperature • Urinalysis and clinical laboratory tests (in accordance with local practice for preoperative assessment) [Note: The investigator may assess eligibility for the study based on the results of laboratory tests on blood and urine samples taken for routine pre-operative assessment up to 2 weeks prior to the Induction Phase of the study and analyzed at a local laboratory] Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will not be eligible for inclusion in this study if any of the following criteria are met: 1. Evidence of clinically significant cardiovascular, neuromuscular, neurological, psychiatric, renal, hepatic or pulmonary disease (including asthma), or impairment of function (as judged by the investigator) 2. Personal or family history of unusual sensitivity to NMBs or other agents used in surgical anesthesia 3. Anatomical characteristics recognized as being associated with difficult intubation conditions, even in the presence of complete jaw and vocal cord relaxation 4. History or evidence of vocal cord polyps and/or paralysis 5. History or evidence of narrow angle glaucoma 6. Personal or family history of malignant hyperthermia 7. History of major thermal injury that required hospitalization 8. Presence of genetically determined disorders of plasma cholinesterase, as determined by medical history 9. History or current evidence of abuse of any drug substance, licit or illicit (including alcohol) 10. Exposure to any of the following agents within 48 hours prior to the Induction Phase of the study, or, if expected to be administered within the first 15 minutes after administration of Study Treatment: antibiotics (except penicillins, cephalosporins, and tetracyclines), i.v. lidocaine (except i.v. lidocaine administered in conjunction with propofol to reduce local irritation), quinidine, trimetaphan, or dexamethasone. 11. Exposure to any of the following agents within 7 days prior to the Induction Phase of the study: tricyclic antidepressants, phenothiazines, anticonvulsants, antihistamines (H1 - or H2 -receptor antagonists), antihypertensives, antiarrhythmics (including procainamide), beta blockers (including propranolol, calcium channel blockers), diuretics (including furosemide, thiazides, mannitol and acetazolamide), potent narcotics (including, but not limited to, oxycodone, methadone, morphine, buprenorphine, hydromorphone), and magnesium or lithium salts. Note: weak opioids including, but not limited to, propoxyphene, tramadol, hydrocodone, codeine, meperidine and tilidine are not reasons for exclusion provided no changes in daily dosage have occurred within 3 days prior to the Induction Phase of the study. 12. Exposure to monoamine oxidase inhibitors within 14 days prior to the Induction Phase of the study. 13. Exposure to anticholinesterase or cholinomimetic agents within 30 days prior to the Induction Phase 14. Previous entry into this or any other study of Gantacurium Chloride for Injection, or participation in any other investigational drug, biologic, or medical device study within 30 days prior to the Induction Phase 15. Pregnant (positive pregnancy test during Screening) or breastfeeding/donating breast milk 16. Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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.;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) | — |
Countries
Denmark, Germany, United Kingdom
Outcome results
None listed