Perioperative Ketamine for Pain With Gastric Bypass

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Ketamine; Laparoscopic Gastric Bypass Surgery

Treatments: Drug: Ketamine; Drug: Standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03448068

17-000301

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Ketamine Therapy

Experimental group

Description:

1. Ketamine 0.3 mg/kg (IBW) bolus with induction. 2. Ketamine infusion 0.2 mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours. 3. Ketamine infusion will not be titrated. 4. Remaining care will be identical to standard therapy group.

Treatment:

Drug: Ketamine

Standard Therapy

Active Comparator group

Description:

1. Calculation ideal body weight (IBW) 2. Pre-op dexamethasone 3. Pre-op midazolam at discretion of anesthesiologist 4. Anesthesia Induction - Propofol and fentanyl, anesthesiologist discretion. Neuromuscular block with succinylcholine and/or rocuronium at discretion of anesthesiologist. Orotracheal intubation. 5. Anesthesia Maintenance - Sevoflurane/rocuronium. Addl. doses of fentanyl, discretion of anesthesiologist. 6. Emergence from anesthesia - Acetaminophen, Ketorolac and Ondansetron unless contraindicated. Sugammadex depending on twitch response per drug manufacturer recommended protocol. 7. Post-Op Analgesia - Hydromorphone, acetaminophen and ketorolac 8. Other post-op care as per usual surgical routine

Treatment:

Drug: Standard therapy