A study to evaluate the safety and effect of Ropin Heavy® injection for spinal anaesthesia in adult subjects
- Conditions
- Health Condition 1: 3- Administration
- Registration Number
- CTRI/2022/03/040917
- Lead Sponsor
- eon Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method