Perioperative Ketamine for Pain With Gastric Bypass
Condition: Laparoscopic Gastric Bypass Surgery; Ketamine
Intervention: Ketamine; Standard therapy
Intervention description: Ketamine 0.3 mg/kg (IBW) bolus with induction. Ketamine infusion 0.2mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.
Ketamine infusion not titrated.; Pre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses.
Other standard surgical post-op care
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.