drugset / Trial / NCT03448068

Perioperative Ketamine for Pain With Gastric Bypass

NCT03448068

Phase 2 Completed 34 enrolled Mayo Clinic
RandomizedParallel-groupOpen-labelTreatment

Summary

Opioid medications such as morphine, hydrocodone and oxycodone are standard for treating pain after surgery, however there are disadvantages. Because of the way opioids work, gastric bypass patients may have an increased risk of having sedation or problems with breathing. In patients with sleep apnea, opioids may increase the risk of severe apnea. Ketamine is an alternative pain medicine that can be used to treat pain after surgery and may have fewer effects on breathing. Using ketamine as part of the regimen may be a better choice for laparoscopic gastric bypass patients. This study is being done to find out if intraoperative ketamine infusion combined with continuation for twenty-four hours post-surgery provides superior pain control and decreases post-operative opioid use versus standard non-ketamine therapy.

Timeline

Start
2018-04-16
Primary completion
2020-01-09
Completion
2020-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.2 mg/kg
Background Acetaminophen Small molecule 1 g
Background Dexamethasone Small molecule 4 mg
Background Fentanyl Other / unclassified 0.5 ug/kg
Background Fentanyl Other / unclassified 1 ug/kg
Background Hydromorphone Other / unclassified 0.2 mg
Background Ketorolac Other / unclassified 15 mg
Background Ketorolac Other / unclassified 30 mg
Background Midazolam Small molecule 1 mg
Background Midazolam Small molecule 2 mg
Background Ondansetron Other / unclassified 4 mg
Background Propofol Small molecule 2 mg/kg
Background Propofol Small molecule 3 mg/kg
Background Rocuronium Other / unclassified
Background Sevoflurane Other / unclassified
Background Sugammadex Other / unclassified 2 mg/kg
Background Sugammadex Other / unclassified 4 mg/kg
Background Suxamethonium Other / unclassified

Indications

No indication recorded.