Perioperative Ketamine for Pain With Gastric Bypass

Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass

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.

Study Overview

• Status: Completed
• Conditions: Ketamine; Laparoscopic Gastric Bypass Surgery
• Intervention / Treatment: Drug: Ketamine; Drug: Standard therapy

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine Therapy; Ketamine 0.3 mg/kg (IBW) bolus with induction.; Ketamine infusion 0.2 mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.; Ketamine infusion will not be titrated.; Remaining care will be identical to standard therapy group.	Drug: Ketamine; 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.
Active Comparator: Standard Therapy; Calculation ideal body weight (IBW); Pre-op dexamethasone; Pre-op midazolam at discretion of anesthesiologist; Anesthesia Induction - Propofol and fentanyl, anesthesiologist discretion. Neuromuscular block with succinylcholine and/or rocuronium at discretion of anesthesiologist. Orotracheal intubation.; Anesthesia Maintenance - Sevoflurane/rocuronium. Addl. doses of fentanyl, discretion of anesthesiologist.; Emergence from anesthesia - Acetaminophen, Ketorolac and Ondansetron unless contraindicated. Sugammadex depending on twitch response per drug manufacturer recommended protocol.; Post-Op Analgesia - Hydromorphone, acetaminophen and ketorolac; Other post-op care as per usual surgical routine	Drug: Standard therapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cumulative Perioperative Opioid Dose	Measured in oral morphine equivalents	approximately 48 hours after induction of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Pain Score 0-12 Hours	Patient reported pain scores at 0-12 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.	approximately 0-12 hours post operatively
Average Pain Score 12-24 Hours	Patient reported pain scores at 12-24 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.	approximately 12-24 hours post operatively
Average Pain Score 24-48 Hours	Patient reported pain scores at 24-48 hours post operatively. Measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. A higher score indicates great pain intensity.	approximately 24-48 hours post operatively
Post-Operative Nausea	Number of subject to experience post-operative nausea	12 hours, 24 hours, and 48 hours
Length of Stay in Hospital	Length of hospital stay measured in hours	Arrival at hospital until discharge from hospital, approximately 2 days
Patient Satisfaction With Pain Control at Time of Hospital Discharge	Self-reported questionnaire at the time of discharge from the hospital rating satisfaction of pain treatment while in the hospital using a scale of 0= extremely dissatisfied, 10 = extremely satisfied.	approximately 1-2 days post-operatively
Patient Satisfaction With Pain Control at Postoperative Visit	Self-reported questionnaire at the time of first post-operative visit with the surgeon, rating the worst amount of pain since being discharged from the hospital using a scale of 0= no pain, 10 = worst pain possible.	approximately 30 days post-operatively

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Andrew W Gorlin, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): January 9, 2020
• Study Completion (Actual): January 9, 2020

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 17-000301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No