Perioperative Ketamine for Pain With Gastric Bypass

Completed · Phase 2

Conditions studied: Laparoscopic Gastric Bypass Surgery, Ketamine

In brief

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.

Key facts

Study ID

NCT03448068

Run by

Mayo Clinic

People needed

34

Starts

2018-04-16

Expected to finish

2020-01-09

Last updated by the study team

2021-04-29

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona
• BMI is ≥ 35 kg/m2
• Consent is able to be obtained as per Mayo Clinic policy

You may not qualify if…

• Intolerance to ketamine
• History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis with psychotic features
• Presence of unstable cardiovascular disease (presence of acute coronary syndrome, unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or stroke)
• Presence of acute elevation of intracranial or intraocular pressure
• Presence of seizure disorder
• History of substance abuse or addiction
• Creatinine greater than 1.5 mg/dL
• End-stage liver disease
• Pregnancy
• Patients with chronic pain and/or chronic opioid therapy will not be excluded to more closely replicate the study patient population of interest. However, patients taking greater than 50 morphine equivalents (ME) per day for greater than 1 month prior to surgery will be excluded.

Where it is running

• Mayo Clinic in Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.