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Perioperative Ketamine for Pain With Gastric Bypass

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ClinicalTrials.gov Identifier: NCT03448068
Recruitment Status : Enrolling by invitation
First Posted : February 27, 2018
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Gorlin, MD, Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Laparoscopic Gastric Bypass Surgery Ketamine Drug: Ketamine Drug: Standard therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine Therapy
  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.
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
  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
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





Primary Outcome Measures :
  1. Total Cumulative Perioperative Opioid Dose [ Time Frame: Induction of anesthesia until 48 hours after induction of anesthesia ]
    Total cumulative perioperative opioid dose will be measured in morphine equivalents.


Secondary Outcome Measures :
  1. Mean Pain Score [ Time Frame: Post-anesthesia care unit (PACU) arrival until 48 hours after induction of anesthesia ]
    Pain was 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.

  2. Number of Subjects Who Needed Anti-emetics During Hospitalization [ Time Frame: Post-anesthesia care unit (PACU) arrival until discharge from hospital, approximately 2 days ]
    This outcome measure will help determine postoperative nausea and vomiting.

  3. Number of Subjects Who Needed Anti-histamines During Hospitalization [ Time Frame: Post-anesthesia care unit (PACU) arrival until discharge from hospital, approximately 2 days ]
    This outcome measure will help determine the number of subjects with pruritus.

  4. Length of stay in hospital [ Time Frame: Arrival at hospital until discharge from hospital, approximately 2 days ]
    Length of stay will be measured in hours and minutes.

  5. Patient satisfaction with pain control at time of hospital discharge [ Time Frame: 1-2 days postoperatively ]
    This will be measured by a survey completed at the time of discharge from the hospital.

  6. Patient satisfaction with pain control at postoperative visit [ Time Frame: Approximately 2-3 weeks after surgery ]
    This will be measured by a survey completed at the postoperative visit with the surgeon.

  7. Adverse Events Monitoring [ Time Frame: Induction of ketamine to up to 30 days postoperatively ]
    All adverse events that have occurred will be monitored to ensure patient safety.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448068


Locations
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United States, Arizona
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Andrew W Gorlin, M.D. Mayo Clinic

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Responsible Party: Andrew Gorlin, MD, Assistant Professor of Anesthesiology, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03448068     History of Changes
Other Study ID Numbers: 17-000301
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketamine
Acetaminophen
Ketorolac
Rocuronium
Succinylcholine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Antipyretics
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuromuscular Depolarizing Agents