drugset / Trial / NCT03603119

Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting for Laparoscopic Surgeries

NCT03603119

RandomizedSingle-groupSingle-blindPrevention

Summary

Postoperative nausea and vomiting(PONV) affects 11 to 60 % of patients undergoing surgery and is a major cause of postoperative morbidity. Risk factors include female gender, non smokers, postoperative use of opioids and a past history of PONV. The simplified Apfel risk score is used to identify patients at risk for PONV. PONV prophylaxis is provided intraoperatively to patients with 2 or more risk factors. In spite of numerous drugs available, control of PONV remains a difficult task. Midazolam is a commonly used drug perioperatively for its anxiolytic and sedative properties. It decreases analgesic requirement and has also been found to have an antiemetic effect. This present study is designed to compare the prophylactic use of iv midazolam with a commonly used combination of dexamethasone-ondansetron in high risk patients (as defined by the modified Apfel score) undergoing laparoscopic surgeries.

Timeline

Start
2018-05-01
Primary completion
2019-11-15
Completion
2019-11-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 8 mg Intravenous
Subject Midazolam Small molecule 2 mg Intravenous
Comparator Ondansetron Other / unclassified 4 mg Intravenous

Indications

No indication recorded.