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Opioid sparing analgesia is extremely important in the post-operative obese population. With more and more obese patients entering the operating room a multi-modal approach to analgesia is crucial. Finding effective alternatives to opioid therapy is the rationale of this proposal. Literature involving ketamine and magnesium in bariatric surgical patients is very sparse.
Patient will be identified by surgeon and consented by member of the research team
Patient will be randomized to one of three groups on the day of surgery
Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump.
The subject will receive ketamine, ketamine plus magnesium or a placebo.
Following surgery, the patient will be taken to the post anesthesia care unit (PACU) and set up with standard ASA monitoring as well as end-tidal CO2 via nasal cannula. A hydromorphone patient controlled analgesia (PCA) pump will be set-up by nursing and given to the patient. Standard dosing of 0.2 mg bolus, every 6 minutes with a maximum 2 mg will be the starting dose as is standard for these patients post-operatively.
Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively.
.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine | Active Comparator | Ketamine: 0.5 mg/kg IV dose |
|
| Ketamine plus magnesium | Active Comparator | Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV |
|
| Placebo | Placebo Comparator | Placebo (normal saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine infusion plus placebo infusion of normal saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Hydromorphone Use | Total hydromorphone use in 1st 24 hours post-operatively. | During surgery and 24 hours post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores Using Verbal Analogue Scale (VAS) | Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain. | Preoperatively and the 1st 24 hours post-op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjib Adhikary, MB, BS,MD | PSHMC College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milton S.Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketamine | Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions |
| FG001 | Ketamine Plus Magnesium | Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion |
| FG002 | Placebo | Placebo (normal saline) Placebo: 2 placebo infusions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions |
| BG001 | Ketamine Plus Magnesium | Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Hydromorphone Use | Total hydromorphone use in 1st 24 hours post-operatively. | Posted | Mean | 95% Confidence Interval | mcg/Kg | During surgery and 24 hours post-op |
|
Perioperative time period (within 24 hours) up to 24 hours post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine | Ketamine: 0.5 mg/kg IV dose Ketamine: Ketamine infusion plus placebo infusion of normal saline Placebo: 2 placebo infusions |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjib D Adhikary | Penn State Health Anesthesiology and Perioperative Medicine | 717-531-6597 | sadhikary1@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2019 | Jul 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008274 | Magnesium |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine plus magnesium |
| Drug |
Ketamine plus magnesium infusion |
|
| Placebo | Other | 2 placebo infusions |
|
|
| Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane | The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision. | Intraoperative period |
| BG002 | Placebo | Placebo (normal saline) Placebo: 2 placebo infusions |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Duration of Surgery | Mean | Standard Deviation | minutes |
|
| Pre-operative Pain Score | Pain Scores will be determined pre-operatively using the Visual Analogue Scale (VAS). The VAS is a 10 point scale, where 0 = no pain and 10 = worst pain a subject has ever felt. | Mean | Standard Deviation | units on a scale |
|
| Pre-operative sedation score | Sedation scoring will be determined using the Modified Ramsay Sedation Scale. The Modified Ramsay Sedation Scale is a 6 point scale used to determine alertness, where 1 = patient is awake, anxious, agitated, or restless and 6 = patient with no response to any stimuli (light, noise, or pain). A higher number represents an increased sedative state. | Median | Standard Deviation | units on a scale |
|
| Pre-operative PONV score | The Pre-Operative PONV score will be determined using the PONV Impact Scale. This scale consists of two questions (rated from 0 to 3) for both questions and the sum of the responses are added for a total PONV score. Question 1 asks if an individual has vomited or had any dry retching, where 0 = Not at all, 1 = Once, 2= Twice, and 3= Three or more times. Question 2 asks if an individual has experienced a feeling of nausea, where 0 = Not at all, 1 = Sometimes, 2 = Often or most of the time, and 3 = All of the time. total score (mean and std deviation) is reported and total ranges from 0-3. | Mean | Standard Deviation | units on a scale |
|
Placebo (normal saline) Placebo: 2 placebo infusions |
|
|
| Secondary | Pain Scores Using Verbal Analogue Scale (VAS) | Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain. | Posted | Mean | 95% Confidence Interval | units on a scale | Preoperatively and the 1st 24 hours post-op |
|
|
|
| Secondary | Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane | The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision. | Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane | Posted | Mean | 95% Confidence Interval | Minimal Alveolar Concentration (MAC) | Intraoperative period |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Ketamine Plus Magnesium | Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV Ketamine plus magnesium: Ketamine plus magnesium infusion | 0 | 34 | 0 | 34 | 0 | 34 |
| EG002 | Placebo | Placebo (normal saline) Placebo: 2 placebo infusions | 0 | 37 | 0 | 37 | 0 | 37 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| Male |
|
|
| 4h after surgery |
|
| 8h after surgery |
|
| 12h after surgery |
|
| 16h after surgery |
|
| 20h after surgery |
|
| 24h after surgery |
|