Perioperative Ketamine for Pain With Gastric Bypass

NCT ID: NCT03448068

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2020-01-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Andrew Gorlin, MD

Assistant Professor of Anesthesiology, College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew W Gorlin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

17-000301

Identifier Type: -

Identifier Source: org_study_id