Perioperative Ketamine for Pain With Gastric Bypass

NCT03448068 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-000301
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Gastric Bypass Surgery; Ketamine

Outcome Measures

Primary Outcomes (1)

• Total Cumulative Perioperative Opioid Dose

  Measured in oral morphine equivalents

  approximately 48 hours after induction of anesthesia

Secondary Outcomes (7)

• Average Pain Score 0-12 Hours

  approximately 0-12 hours post operatively

• Average Pain Score 12-24 Hours

  approximately 12-24 hours post operatively

• Average Pain Score 24-48 Hours

  approximately 24-48 hours post operatively

• Post-Operative Nausea

  12 hours, 24 hours, and 48 hours

• Length of Stay in Hospital

  Arrival at hospital until discharge from hospital, approximately 2 days

Study Arms (2)

Ketamine Therapy

EXPERIMENTAL

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

Standard Therapy

ACTIVE COMPARATOR

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

Interventions

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.

Ketamine Therapy

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

Standard Therapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Ketamine; Standard of Care

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Andrew W. Gorlin
• Organization: Mayo Clinic

Gorlin.Andrew@mayo.edu

480-342-2446

Study Officials

• Andrew W Gorlin, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, College of Medicine

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 27, 2018
• Study Start: April 16, 2018
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Locations

US (1)