A Phase III study understand the,Efficacy, Safety and Tolerability Study of Sugammadex Injection 100mg/ml as compared with Neostigmine Methylsulfate Injection 0.5mg/ml in subjects scheduled for surgical procedure with Shallow Neuromuscular Blockade
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/08/035471
- Lead Sponsor
- BDR Pharmaceuticals Internationals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Male and Female subjects of age group �18 to �65 years.
Subjects with American Society of Anesthesiologists (ASA) class I ââ?¬â??II
ASA ClassificationDefinitionAdult Examples, Including, but not Limited to:
ASA IA normal healthy subjectHealthy, non-smoking, no or minimal alcohol use
ASA IIA subject with mild systemic diseaseMild diseases only without substantive functional limitations. Examples include (but not limited to): current smoker, social alcohol drinker, obesity (30
Subjects scheduled for surgical procedures under general anesthesia (except cyclopropane or halothane anesthesia) with the use of succinylcholine for tracheal intubation and rocuronium for maintenance of shallow neuromuscular block.
Subjects with creatinine clearance � 60 ml/min.
Subjects scheduled for surgical procedure in supine position.
Written informed consent from the patient, legally acceptable representative or parent and able to follow study procedures.
Subjects who are not able to or not willing to sign an IRB/IEC approved consent form.
Subjects in whom a difficult intubation is expected because of anatomical malformations.
Subjects who are known or suspected to have neuromuscular disorders impairing neuromuscular block (NMB) and/or significant renal dysfunction.
Subjects who are known or suspected to have a personal or family history of malignant hyperthermia and skeletal muscle myopathies.
Subjects who are known or suspected to have an allergy or hypersensitivity to narcotics, muscle relaxants or other medication used during general anesthesia, bromide ion.
Subjects in the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury.
Subjects who are receiving prohibited medication as described in Appendix A in a dose and/or at a time point known to interfere with neuromuscular blocking agents such as antibiotics, anticonvulsants and Mg2+.
Subjects in whom the use of neostigmine and/or glycopyrrolate may be contraindicated such as subjects with mechanical obstruction of gastrointestinal or urinary tracts, peritonitis or doubtful bowel viability, use in conjunction with depolarising muscle relaxants such as suxamethonium.
Subjects with severe hepatic impairment with or without coagulopathy.
Subjects who are on anticoagulation therapy for a pre-existing or comorbid condition.
Subjects with pre-existing bradycardia, cardiac arrhythmia or recent coronary occlusion.
Subjects with history of epilepsy, vagotonia, hyperthyroidism, peptic ulceration or Parkinsonism.
Participation in any clinical study within 30 days before the administration of Investigational Product.
Subjects with positive serology for Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human Immunodeficiency virus (HIV).
Subjects with suspected signs and symptoms of COVID-19 / confirmed novel coronavirus infection (COVID-19) or with a recent history of travel/contact with any COVID-19 positive subject/isolation/quarantine in last 14 days.
Pregnant or lactating women.
Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study, including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate superiority (faster recovery) of Sugammadex compared to neostigmine from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation)Timepoint: �Time from start of administration of Sugammadex/Neostigmine to recovery of the T4/T1 ratio to 0.9 in rocuronium group.
- Secondary Outcome Measures
Name Time Method To evaluate safety and tolerability of the investigational product.Timepoint: Number of participants with clinical signs of recovery assessed by level of consciousness (by Glasgow Coma Scale), 5 second head lift and muscle weakness (by MRC scale of 0 to 5 for upper limb). <br/ ><br>The incidence, nature, and severity of adverse events including adverse drug reactions. <br/ ><br>