CTRI/2013/11/004173Active, not recruitingPhase 3
Prospective, observer blind, randomized, parallel group, comparative, 2-arm study to evaluate safety and efficacy of Cisatracuruim Besylate versus Atracurium Besylate for neuromuscular blockade in adult patients, undergoing diagnostic or therapeutic surgical procedures.
Themis Medicare Limited5 sites in 1 country200 target enrollmentStarted: November 19, 2013Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Themis Medicare Limited
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Efficacy parameters
Study Overview
Brief Summary
Prospective, observer blind, randomized, parallel group, comparative, 2- arm study to evaluate safety and efficacy of cisatracurium besylate versus atracurium besylate for neuromuscular blockade in adult patients undergoing diagnostic or therapeutic surgical procedures.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria
- •Patients of either sex in the age group between 18 to 65 years.
- •Patients scheduled for elective diagnostic / therapeutic surgical procedure to be completed within 120 minutes with an ASA status ranging from P1 to P4
- •Subjects who provide a written informed consent to abide by the study requirements.
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
- •Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
- •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.
- •Patients suffering from organic neurological disorders, psychiatric illnesses and H/o drug abuse.
- •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.
- •Pregnant and lactating females.
- •Patients simultaneously participating in another clinical study.
Outcomes
Primary Outcomes
Efficacy parameters
Time Frame: 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 Outcomes
- Safety parameters-(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.)
Investigators
Study Sites (5)
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