A prospective, observer blind, randomized, parallel group, comparative, 2-arm study to evaluate the safety and efficacy of Cisatracurium Besylate Injection versus Atracurium Besylate for neuromuscular blockade in adult patients undergoing diagnostic or therapeutic surgical procedures.
Phase 3
Active, not recruiting
- Conditions
- Neuromuscular Blockade in adult patients undergoing diagnostic or therapeutic surgical procedures
- Registration Number
- CTRI/2013/11/004173
- Lead Sponsor
- Themis Medicare Limited
- 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.**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Inclusion Criteria 1.
- 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 3.
- 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 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy parameters 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (5)
C.S.M.M./KGMU University
🇮🇳Lucknow, UTTAR PRADESH, India
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dr. D. Y. Patil Medical College & Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Medica Superspecialty Hospital
🇮🇳Kolkata, WEST BENGAL, India
Sri Siddhartha Medical College and Research Institute
🇮🇳Tumkur, KARNATAKA, India
C.S.M.M./KGMU University🇮🇳Lucknow, UTTAR PRADESH, IndiaProf Dr Jaishri BograPrincipal investigator09839075895lkojbogra@yahoo.in