Overview

Perioperative Ketamine for Pain With Gastric Bypass

Status:
Completed
Trial end date:
2020-01-09
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Acetaminophen
Ketamine
Ketorolac
Rocuronium
Succinylcholine
Criteria
Inclusion Criteria:

1. Patients undergoing laparoscopic gastric bypass at Mayo Clinic in Arizona

2. BMI is ≥ 35 kg/m2

3. Consent is able to be obtained as per Mayo Clinic policy

Exclusion Criteria:

1. Intolerance to ketamine

2. History of schizophrenia, schizoaffective disorder, or other psychiatric diagnosis
with psychotic features

3. Presence of unstable cardiovascular disease (presence of acute coronary syndrome,
unstable angina, hypertension emergency, acute transient ischemic attack (TIA) or
stroke)

4. Presence of acute elevation of intracranial or intraocular pressure

5. Presence of seizure disorder

6. History of substance abuse or addiction

7. Creatinine greater than 1.5 mg/dL

8. End-stage liver disease

9. Pregnancy

10. 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.