Clinical trial NCT03448068: Perioperative Ketamine for Pain With Gastric Bypass
Official title: Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laparoscopic Gastric Bypass Surgery
Ketamine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Total Cumulative Perioperative Opioid Dose
timeFrame: approximately 48 hours after induction of anesthesia
Secondary outcomes:
measure: Average Pain Score 0-12 Hours
timeFrame: approximately 0-12 hours post operatively
measure: Average Pain Score 12-24 Hours
timeFrame: approximately 12-24 hours post operatively
measure: Average Pain Score 24-48 Hours
timeFrame: approximately 24-48 hours post operatively
measure: Post-Operative Nausea
timeFrame: 12 hours, 24 hours, and 48 hours
measure: Length of Stay in Hospital
timeFrame: Arrival at hospital until discharge from hospital, approximately 2 days
measure: Patient Satisfaction With Pain Control at Time of Hospital Discharge
timeFrame: approximately 1-2 days post-operatively
measure: Patient Satisfaction With Pain Control at Postoperative Visit
timeFrame: approximately 30 days post-operatively
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Andrew W Gorlin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: