CTRI/2024/04/066242
Not yet recruiting
Phase 4
Comparison of Efficacy and Safety Profile of PreEmptive Ondansetron and Ephedrine for prevention of hypotension under Spinal Anaesthesia: A Prospective Double blinded Randomized Controlled Trial
Not provided1 site in 1 country144 target enrollmentStarted: May 1, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- To compare the efficacy of the two study drugs for prevention of Incidence of Hypotension
Overview
Brief Summary
This study is a double blind randomised controlled trial comparing efficacy and safety profile of PreEmptive Ondansetron and Ephedrine for prevention of hypotension under spinal anaesthesia in 144patients admitted at AIIMS Gorakhpur for infraumbilical surgeries.
Primary outcome is to compare efficacy of two study drugs for prevention of incidence of hypotension.Secondary outcome are to compare hemodynamic changes and to compare side effects and complications if any .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA Class I.
Exclusion Criteria
- •Patient’s refusal Infection at the site Coagulation abnormality Allergy to study drugs Patient receiving Ondansetron Repeat or failed spinal.
Outcomes
Primary Outcomes
To compare the efficacy of the two study drugs for prevention of Incidence of Hypotension
Time Frame: Intraoperative
Secondary Outcomes
- To compare hemodynamic changes in both the study groups
Investigators
Dr Ashutosh kumar
All India institute of medical sciences Gorakhpur
Study Sites (1)
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