Phase 2 N=34 Randomized Treatment

Perioperative Ketamine for Pain With Gastric Bypass

Laparoscopic Gastric Bypass Surgery · Ketamine

Bottom Line

View on ClinicalTrials.gov: NCT03448068 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Total Cumulative Perioperative Opioid Dose — 179.9; 248.6 Morphine Equivalents — p=0.03

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ketamine (Drug); Standard therapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Cumulative Perioperative Opioid Dose	179.9; 248.6	0.03 sig
SECONDARY Average Pain Score 0-12 Hours	3.4; 4.2	0.2252
SECONDARY Average Pain Score 12-24 Hours	2.6; 3.7	0.0610
SECONDARY Average Pain Score 24-48 Hours	3.1; 3.8	0.2720
SECONDARY Post-Operative Nausea	10; 9; 6; 2; 3; 3	0.7298
SECONDARY Length of Stay in Hospital	43.9; 36.7	0.2
SECONDARY Patient Satisfaction With Pain Control at Time of Hospital Discharge	9.5; 8.3	—
SECONDARY Patient Satisfaction With Pain Control at Postoperative Visit	3.6; 6.2	—

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

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03448068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.