drugset / Trial / NCT02997800

The Effect of Intraoperative Labetalol on Time to Discharge

NCT02997800

Phase 2 Completed 172 enrolled Dr. Robert Tanzola
RandomizedParallel-groupDouble-blindTreatment

Summary

Patients coming for surgery often receive opioid medications, like fentanyl, to treat pain. Opioids however have many unpleasant side effects including nausea and vomiting, itching, sedation, and decreased breathing. During laparoscopic surgery increases in heart and blood pressure are often attributed to pain. It has been shown that by treating these changes with medications such as esmolol, instead of opioids, side effects and time to discharge from hospital can be reduced. Labetalol is a drug that is similar to esmolol but may have advantages over it. It is more effective at controlling both heart rate and blood pressure and it is easier and less costly to use. This study is investigating labetalol in patients having laparoscopic gallbladder surgery and comparing it to esmolol and fentanyl. Patients will be treated with one of these drugs during surgery to control heart rate and blood pressure and the effects on time to discharge, pain scores, frequency of side effects, and narcotic requirements will be observed in the recovery room. It is thought that labetalol will be shown to be as effective as esmolol and that both drugs that minimize fentanyl will show reduced time to discharge, fewer side effects, and effective treatment of heart rate and blood pressure.

Timeline

Start
2012-11
Primary completion
2019-01
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Esmolol Other / unclassified 5 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 25 ug Intravenous
Subject Labetalol Small molecule 5 mg Intravenous

Indications