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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Ketamine Therapy
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
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
- 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.
- 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 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.
- 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.
- 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.
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
|United States, Arizona|
|Mayo Clinic in Arizona|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||Andrew W Gorlin, M.D.||Mayo Clinic|