Health Condition 1: null- Neuromuscular Blockade in adult patients undergoing diagnostic or therapeutic surgical procedures
Conditions
Interventions
Intervention1: Cisatracurium Besylate Injection: Initial dose will be 0.15 to 0.2 mg/kg prior to intubation
Maintenance doses of 0.03 mg/kg each will sustain neuromuscular block for approximately 20 m
Sponsors
Themis Medicare Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Patients of either sex in the age group between 18 to 65 years. 2. Patients scheduled for elective diagnostic / therapeutic surgical procedure to be completed within 120 minutes with an ASA status ranging from P1 to P4 3. Subjects who provide a written informed consent to abide by the study requirements.
Exclusion criteria
Exclusion criteria: 1. Patients undergoing emergency surgical procedure / surgical procedure with likely duration for completion 120 minutes. 2. Patients receiving medication known to interfere with neuromuscular blockers for e.g. : anti-convulsants, amino glycosides or polypeptide antibiotics, magnesium 3. Patients with anticipated difficult intubation (Mallampati score III and more) 4. Patients with diseases affecting neuromuscular transmission (myasthenia gravis or myopathies). 5. Subjects known or suspected to have a (family) history of malignant hyperthermia 6. Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia 7. Patients treated with any other oral / parenteral opioids or benzodiazepines within 1 week prior to the study or will continue to receive these drugs as concomitant medication during the study period. 8. Patients suffering from organic neurological disorders, psychiatric illnesses and H/o drug abuse. 9. Patients with known hypersensitivity to any of the ingredients of the test / comparator formulation. 10.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. 11. Pregnant and lactating females. 12. Patients simultaneously participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy parametersTimepoint: The train of four will be recorded every 10 min for the first 2 h (period of surgery) and then at least hourly until complete spontaneous recovery (maximum period of 6 hours) as evident from recording of train-of-four without fade phenomenon. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters-Timepoint: The BP, pO2, respiratory rate, pulse (HR), QTc interval(ECG), will be recorded prior to anaesthesia, during anesthesia and surgery at 10 minutes interval till end of surgery, while in the post operative period will be recorded at 2 hrs, 4hrs and 6 hours. Haematological and serological investigations will be done before the procedure and at the end of 6 hours after surgery. | — |
Countries
India
Contacts
Public ContactDr Sumedh M Gaikwad
Dr. D.Y.Patil Medical College & Hospital,
Outcome results
None listed