Perioperative Ketamine for Pain With Gastric Bypass

Phase 2

Completed

• Conditions: Ketamine; Laparoscopic Gastric Bypass Surgery
• Interventions: Drug: Standard therapy; Drug: Ketamine

• Registration Number: NCT03448068
• Lead Sponsor: Mayo Clinic

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-02-27
• Study Start: 2018-04-16
• Primary Completion: 2020-01-09
• Study Completion: 2020-01-09
• Results First Submitted: 2021-03-08
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-05
• Last Update Submitted: 2021-04-05
• Results First Posted: 2021-04-29
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Therapy	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
Ketamine Therapy	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
Total Cumulative Perioperative Opioid Dose	approximately 48 hours after induction of anesthesia	Measured in oral morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Average Pain Score 24-48 Hours	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	12 hours, 24 hours, and 48 hours	Number of subject to experience post-operative nausea
Patient Satisfaction With Pain Control at Time of Hospital Discharge	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	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.
Average Pain Score 0-12 Hours	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	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.
Length of Stay in Hospital	Arrival at hospital until discharge from hospital, approximately 2 days	Length of hospital stay measured in hours

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States