NCT02334059

Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.

Detailed description

1. Patient will be identified by surgeon and consented by member of the research team 2. Patient will be randomized to one of three groups on the day of surgery 3. Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump. 4. The subject will receive ketamine, ketamine plus magnesium or a placebo. 5. Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively. 6. Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively. .

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Ketamine	Ketamine infusion plus placebo infusion of normal saline
DRUG	Ketamine plus magnesium	Ketamine plus magnesium infusion
OTHER	Placebo	2 placebo infusions

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-03-13
• Completion: 2019-03-13
• First posted: 2015-01-08
• Last updated: 2020-06-01
• Results posted: 2019-11-19

Locations

1 site across 1 country: United States