Obesity
Conditions
Keywords
opioid sparing, ketamine, obese, magnesium
Brief summary
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.
Detailed description
1. Patient will be identified by surgeon and consented by member of the research team 2. Patient will be randomized to one of three groups on the day of surgery 3. Following securement of the endotracheal tube, the study medication will be administered over 10 minutes via an IV infusion pump. 4. The subject will receive ketamine, ketamine plus magnesium or a placebo. 5. 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. 6. Primary outcome will be the total amount of hydromorphone used in the first 24 hours post-operatively. .
Interventions
DRUGKetamine
Ketamine infusion plus placebo infusion of normal saline
DRUGKetamine plus magnesium
Ketamine plus magnesium infusion
OTHERPlacebo
2 placebo infusions
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects undergoing laparoscopic sleeve gastrectomy 2. Consenting adults age 18-80 3. ASA II to ASA III 4. Ability to understand and use a PCA 5. Required to be hospitalized for at least 24 hours post-op
Exclusion criteria
1. Patient refusal 2. Chronic opiate use (daily opiate use for \>3 months) 3. Chronic Kidney disease (Creatinine\>2) 4. Known allergy or adverse effect of ketamine, magnesium or hydromorphone 5. Patients with documented psychiatry (Maniac or MDP) history 6. Patient unable to give informed consent 7. Patient with limited or no English fluency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Hydromorphone Use | During surgery and 24 hours post-op | Total hydromorphone use in 1st 24 hours post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores Using Verbal Analogue Scale (VAS) | Preoperatively and the 1st 24 hours post-op | 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. |
| Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane | Intraoperative period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Ketamine: 0.5 mg/kg IV dose
Ketamine: Ketamine infusion plus placebo infusion of normal saline
Placebo: 2 placebo infusions | 37 |
| 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 | 34 |
| Placebo Placebo (normal saline)
Placebo: 2 placebo infusions | 37 |
| Total | 108 |
Baseline characteristics
| Characteristic | Ketamine | Ketamine Plus Magnesium | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 43.68 years STANDARD_DEVIATION 10.82 | 44.15 years STANDARD_DEVIATION 11.91 | 39.97 years STANDARD_DEVIATION 11.6 | 42.56 years STANDARD_DEVIATION 11.49 |
| BMI | 47.48 kg/m2 STANDARD_DEVIATION 9.85 | 45.57 kg/m2 STANDARD_DEVIATION 6.73 | 47.37 kg/m2 STANDARD_DEVIATION 8.7 | 46.84 kg/m2 STANDARD_DEVIATION 8.53 |
| Duration of Surgery | 55.14 minutes STANDARD_DEVIATION 8.25 | 67.06 minutes STANDARD_DEVIATION 15.12 | 64.78 minutes STANDARD_DEVIATION 13.23 | 62.19 minutes STANDARD_DEVIATION 13.39 |
| Pre-operative Pain Score | 0.27 units on a scale STANDARD_DEVIATION 1.04 | 0.35 units on a scale STANDARD_DEVIATION 0.95 | 0.41 units on a scale STANDARD_DEVIATION 1.3 | 0.34 units on a scale STANDARD_DEVIATION 1.1 |
| Pre-operative PONV score | 0.16 units on a scale STANDARD_DEVIATION 0.5 | 0.03 units on a scale STANDARD_DEVIATION 0.17 | 0.14 units on a scale STANDARD_DEVIATION 0.54 | 0.11 units on a scale STANDARD_DEVIATION 0.44 |
| Pre-operative sedation score | 2 units on a scale STANDARD_DEVIATION 0 | 1.97 units on a scale STANDARD_DEVIATION 0.17 | 2 units on a scale STANDARD_DEVIATION 0.16 | 2 units on a scale STANDARD_DEVIATION 0.14 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 37 participants | 34 participants | 37 participants | 108 participants |
| Sex: Female, Male Female | 27 Participants | 29 Participants | 29 Participants | 85 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 8 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 34 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 34 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 34 | 0 / 37 |
Outcome results
Primary
Total Hydromorphone Use
Total hydromorphone use in 1st 24 hours post-operatively.
Time frame: During surgery and 24 hours post-op
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ketamine | Total Hydromorphone Use | PACU | 41.9 mcg/Kg |
| Ketamine | Total Hydromorphone Use | Intraoperative | 161.5 mcg/Kg |
| Ketamine Plus Magnesium | Total Hydromorphone Use | Intraoperative | 159.6 mcg/Kg |
| Ketamine Plus Magnesium | Total Hydromorphone Use | PACU | 47.8 mcg/Kg |
| Placebo | Total Hydromorphone Use | PACU | 47.3 mcg/Kg |
| Placebo | Total Hydromorphone Use | Intraoperative | 195.9 mcg/Kg |
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.
Time frame: Intraoperative period
Population: Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane | 4.05 Minimal Alveolar Concentration (MAC) |
| Ketamine Plus Magnesium | Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane | 4.02 Minimal Alveolar Concentration (MAC) |
| Placebo | Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane | 4.34 Minimal Alveolar Concentration (MAC) |
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.
Time frame: Preoperatively and the 1st 24 hours post-op
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | 20h after surgery | 3.22 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | 4h after surgery | 3.89 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | 16h after surgery | 2.97 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | 24h after surgery | 3.24 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | 8h after surgery | 3.67 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | 12h after surgery | 3.16 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | PACU | 5.78 units on a scale |
| Ketamine | Pain Scores Using Verbal Analogue Scale (VAS) | Prior to Surgery | 0.41 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | 12h after surgery | 3.91 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | PACU | 6.03 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | 4h after surgery | 4.29 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | 24h after surgery | 3.48 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | Prior to Surgery | 0.35 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | 16h after surgery | 3.64 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | 20h after surgery | 4.13 units on a scale |
| Ketamine Plus Magnesium | Pain Scores Using Verbal Analogue Scale (VAS) | 8h after surgery | 3.75 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | 24h after surgery | 3.33 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | PACU | 5.95 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | 8h after surgery | 3.64 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | 12h after surgery | 2.69 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | 16h after surgery | 3.09 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | 20h after surgery | 2.94 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | Prior to Surgery | 0.27 units on a scale |
| Placebo | Pain Scores Using Verbal Analogue Scale (VAS) | 4h after surgery | 4.65 units on a scale |