Perioperative Ketamine for Pain With Gastric Bypass

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    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.
  • Standard therapy (DRUG)
    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

Condition or Disease

  • Laparoscopic Gastric Bypass Surgery
  • Ketamine

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 69 Years
    Enrollment: 34 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 16, 2018 ACTUAL
    Primary Completion: Jan 09, 2020 ACTUAL
    Completion Date: Jan 09, 2020 ACTUAL
    Study First Posted: Feb 27, 2018 ACTUAL
    Results First Posted: Apr 29, 2021 ACTUAL
    Last Updated: Apr 05, 2021

    Sponsors / Collaborators

    Lead Sponsor: Mayo Clinic
    Responsible Party: N/A

    Location

    Phoenix, Arizona, USA

    Participant Groups

    • 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.

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 69
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    • Measured in oral morphine equivalents

    Secondary Outcomes

    • 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.

    • 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.

    • 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.

    • Number of subject to experience post-operative nausea

    • Length of hospital stay measured in hours

    • 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.

    • 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.

    More Details

    NCT Number: NCT03448068
    Other IDs: 17-000301
    Study URL: https://clinicaltrials.gov/study/NCT03448068
    Last updated: Sep 29, 2023