A Multicentre, Open Label, Post Marketing Surveillance Study to Evaluate the Safety and Efficacy of Ropin Heavy® [Ropivacaine Hydrochloride 0.75% (7.5mg/mL) in Dextrose 8% (80mg/mL)] injection for spinal anaesthesia in adult subjects ?

eon Laboratories Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•1. Male and female subjects of age between 18 to 65 years (both inclusive).
•2. Subjects belonging to ASA Grade I to II.
•3. Subjects undergoing surgeries under spinal anaesthesia of duration =3 hours.
•4. Subjects willing to sign informed consent for participation in the study.

•1. Subjects with contraindications for spinal anaesthesia.
•2. Subjects receiving treatment with MAO inhibitors, Phenothiazines and Tricyclic antidepressants within 14 days prior to participation in the trial.
•3. Subjects with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
•4. Subjects with suspected inability to comply with the study procedure.
•5. Subjects with known hypersensitivity to the investigational medicinal products.
•6. Female subjects who are pregnant or lactating.
•7. Female subjects who are not ready to use acceptable contraceptive methods during the course of study.

发起方

eon Laboratories Ltd