A study comparing the use of two drugs, Granisetron and Ondansetron, for the prevention of nausea and vomiting after surgical procedures under general anaesthesia with inhalational anaesthetic drugs
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ABSTRACT: Intervention1: i.v. granisetron: Granisetron is a serotonin 5-HT3 receptor antagonist that is used as an antiemetic to treat nausea and vomiting after chemotherapy or radiotherapy. Its primary function is to inhibit the activity of the vagus nerve, which activates the vomiting centre in the medulla oblongata. It is on the WHOs List of Essential Medicines. Granisetron is a medication that is well-tolerated and has few side effects. The most generally reported side effects of its use are headache, dizziness, and constipation. There have been no significant drug interactions reported with this drugs use. Patients will receive 2 mg granisetron single dose iv bolus before extubation.
Control Intervention1: ONDANSETRON: Studies have proved the benefit of intravenous granisetron in its adverse event profile and its long action when compared to the standard of care (intravenous ondansetron). But these studies are for certain specific subsets of patients undergoing certain surgical procedures. We plan to compare its safety and efficacy in a wide range of patients & disease profile undergoing surgery under general anaesthesia.Patients will receive 4mg ondansetron i.v. (SOC) i.v. single bolus dose before extubation.
Primary outcome(s): To compare the efficacy & safety of granisetron i.v. vs standard of care ondansetron i.v. in patients undergoing surgery under general anaesthesia.Timepoint: First 24 hours, grouped as 0-1 hours,1-3 hours,3-6 hours,6-12 hours,12-24 hours post surgery
Study Design: Randomized, Parallel Group Trial Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded
DISEASE(S): Chronic Mastoiditis,Acute Appendicitis With Generalized Peritonitis,Benign Neoplasm Of Unspecified Breast,Chronic Cholecystitis,Intestinal Adhesions [bands] Withobstruction (postinfection)
PROVIDER: 2722288 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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