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Perioperative Ketamine for Pain With Gastric Bypass

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ClinicalTrials.gov Identifier: NCT03448068
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : April 29, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Andrew Gorlin, MD, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 27, 2018
Results First Submitted Date  ICMJE March 8, 2021
Results First Posted Date  ICMJE April 29, 2021
Last Update Posted Date April 29, 2021
Actual Study Start Date  ICMJE April 16, 2018
Actual Primary Completion Date January 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2021)
Total Cumulative Perioperative Opioid Dose [ Time Frame: approximately 48 hours after induction of anesthesia ]
Measured in oral morphine equivalents
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2021)
  • Average Pain Score 0-12 Hours [ Time Frame: approximately 0-12 hours post operatively ]
    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.
  • Average Pain Score 12-24 Hours [ Time Frame: approximately 12-24 hours post operatively ]
    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.
  • Average Pain Score 24-48 Hours [ Time Frame: approximately 24-48 hours post operatively ]
    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.
  • Post-Operative Nausea [ Time Frame: 12 hours, 24 hours, and 48 hours ]
    Number of subject to experience post-operative nausea
  • Length of Stay in Hospital [ Time Frame: Arrival at hospital until discharge from hospital, approximately 2 days ]
    Length of hospital stay measured in hours
  • Patient Satisfaction With Pain Control at Time of Hospital Discharge [ Time Frame: approximately 1-2 days post-operatively ]
    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.
  • Patient Satisfaction With Pain Control at Postoperative Visit [ Time Frame: approximately 30 days post-operatively ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • Patient satisfaction with pain control [ Time Frame: At postoperative visit with surgeon, approximately 2-3 weeks ]
    This will be measured by a short survey completed at postoperative visit with surgeon
  • Adverse Events Monitoring [ Time Frame: Induction of ketamine to up to 30 days postoperatively. ]
    We will monitor any adverse events that have occurred to ensure patient safety.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perioperative Ketamine for Pain With Gastric Bypass
Official Title  ICMJE Low-dose Ketamine Infusions for Perioperative Pain Management in Patients Undergoing Laparoscopic Gastric Bypass
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparoscopic Gastric Bypass Surgery
  • Ketamine
Intervention  ICMJE
  • 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.

  • 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

Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ketamine
  • 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
    Intervention: Drug: Standard therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2018)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 9, 2020
Actual Primary Completion Date January 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448068
Other Study ID Numbers  ICMJE 17-000301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Gorlin, MD, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew W Gorlin, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP