CTRI/2019/05/019171CompletedNot Applicable
A double blind randomized control study to compare the antiemetic efficacy of ondansetron versus ondansetron and dexamethasone combination in patients undergoing breast surgeries.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bangalore Baptist Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Nausea and vomiting
Study Overview
Brief Summary
Serotonin (5 Hydroxy tryptamine) receptor antagonists like ondansetron are the most commonly used drug for the prevention and treatment of Post-Operative nausea and vomiting (PONV) in all surgeries.
It has been found that there is a very high incidence of PONV in patients undergoing breast surgeries.
It has been found that the glucocorticoid, dexamethasone is a very potent and long acting anti emetic and it also augments the antiemetic property of other drugs.
Thus in our study we are comparing the efficacy of ondansetron alone or when used in combination with dexamethasone is better for preventing PONV and need for rescue antiemetic in patients undergoing breast surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •All females belonging to ASA I and II undergoing breaast surgeries.
Exclusion Criteria
- •1.Patients on chronic steroid therapy , 2.pregnant/lactating women, 3.patients having history of motion sickness 4.patients on preoperative chemotherapy , 5.patients having received antiemetic ,steroid within 24hrs of surgery 6.patients suffering from diabetes mellitus, intestinal obstruction, hiatus hernia, hepatic and renal diseases 7.patients with prolonged QTC interval.
Outcomes
Primary Outcomes
Nausea and vomiting
Time Frame: within 24hrs after breast surgeries.
Secondary Outcomes
- to assess the need for resscue antiemetic in 24hrs after breast surgery(within 24hours)
Investigators
Study Sites (1)
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