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Completed

NCT Number: NCT03448068

Perioperative Ketamine for Pain With 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.

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Key information

Conditions

Laparoscopic Gastric Bypass Surgery Ketamine

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Total Cumulative Perioperative Opioid Dose

    Time frame: approximately 48 hours after induction of anesthesia

    Measured in oral morphine equivalents

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Post-Operative Nausea

    Time frame: 12 hours, 24 hours, and 48 hours

    Number of subject to experience post-operative nausea

  5. Length of Stay in Hospital

    Time frame: Arrival at hospital until discharge from hospital, approximately 2 days

    Length of hospital stay measured in hours

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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