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

• Conditions: Health Condition 1: null- Neuromuscular Blockade in adult patients undergoing diagnostic or therapeutic surgical procedures

• Registration Number: CTRI/2013/11/004173
• Lead Sponsor: Themis Medicare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified