Ketamine, Laparoscopic Gastric Bypass Surgery
Conditions
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.
Interventions
DRUGKetamine
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.
DRUGStandard 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
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cumulative Perioperative Opioid Dose | approximately 48 hours after induction of anesthesia | Measured in oral morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| Length of Stay in Hospital | Arrival at hospital until discharge from hospital, approximately 2 days | Length of hospital stay measured in hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Therapy Subjects received a ketamine bolus (0.3 mg/kg IV IBW) with induction; a ketamine infusion (0.2 mg/kg/hr IBW) was started after induction and terminated the next morning after surgical team rounds or at 24 hours | 17 |
| Standard Therapy Subjects received standard of care anesthesia | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Standard Therapy | Total | Ketamine Therapy |
|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 10.2 | 51.5 years STANDARD_DEVIATION 11 | 54.2 years STANDARD_DEVIATION 11.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 17 participants | 34 participants | 17 participants |
| Sex: Female, Male Female | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Male | 2 Participants | 7 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 13 / 17 | 11 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Total Cumulative Perioperative Opioid Dose
Measured in oral morphine equivalents
Time frame: approximately 48 hours after induction of anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Total Cumulative Perioperative Opioid Dose | 179.9 Morphine Equivalents | Standard Deviation 113.1 |
| Standard Therapy | Total Cumulative Perioperative Opioid Dose | 248.6 Morphine Equivalents | Standard Deviation 91.6 |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Average Pain Score 0-12 Hours
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.
Time frame: approximately 0-12 hours post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Average Pain Score 0-12 Hours | 3.4 mm | Standard Deviation 2.2 |
| Standard Therapy | Average Pain Score 0-12 Hours | 4.2 mm | Standard Deviation 1.5 |
p-value: 0.2252t-test, 2 sided
Secondary
Average Pain Score 12-24 Hours
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.
Time frame: approximately 12-24 hours post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Average Pain Score 12-24 Hours | 2.6 mm | Standard Deviation 1.9 |
| Standard Therapy | Average Pain Score 12-24 Hours | 3.7 mm | Standard Deviation 1.4 |
p-value: 0.061t-test, 2 sided
Secondary
Average Pain Score 24-48 Hours
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.
Time frame: approximately 24-48 hours post operatively
Population: 2 subjects were discharged early so data was not collected or analyzed for 1 subject from the ketamine therapy group and 1 subject from the standard therapy group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Average Pain Score 24-48 Hours | 3.1 mm | Standard Deviation 1.9 |
| Standard Therapy | Average Pain Score 24-48 Hours | 3.8 mm | Standard Deviation 1.5 |
p-value: 0.272t-test, 2 sided
Secondary
Length of Stay in Hospital
Length of hospital stay measured in hours
Time frame: Arrival at hospital until discharge from hospital, approximately 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Length of Stay in Hospital | 43.9 Hours | Standard Deviation 18 |
| Standard Therapy | Length of Stay in Hospital | 36.7 Hours | Standard Deviation 14 |
p-value: 0.2t-test, 2 sided
Secondary
Patient Satisfaction With Pain Control at Postoperative Visit
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.
Time frame: approximately 30 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Patient Satisfaction With Pain Control at Postoperative Visit | 3.6 score on a scale | Standard Deviation 3.4 |
| Standard Therapy | Patient Satisfaction With Pain Control at Postoperative Visit | 6.2 score on a scale | Standard Deviation 2.3 |
Secondary
Patient Satisfaction With Pain Control at Time of Hospital Discharge
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.
Time frame: approximately 1-2 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine Therapy | Patient Satisfaction With Pain Control at Time of Hospital Discharge | 9.5 score on a scale | Standard Deviation 0.9 |
| Standard Therapy | Patient Satisfaction With Pain Control at Time of Hospital Discharge | 8.3 score on a scale | Standard Deviation 1.9 |
Secondary
Post-Operative Nausea
Number of subject to experience post-operative nausea
Time frame: 12 hours, 24 hours, and 48 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketamine Therapy | Post-Operative Nausea | Nausea 1st 12 hours | 10 Participants |
| Ketamine Therapy | Post-Operative Nausea | Nausea 2nd 12 hours | 6 Participants |
| Ketamine Therapy | Post-Operative Nausea | Nausea 2nd 24 hours | 3 Participants |
| Standard Therapy | Post-Operative Nausea | Nausea 1st 12 hours | 9 Participants |
| Standard Therapy | Post-Operative Nausea | Nausea 2nd 12 hours | 2 Participants |
| Standard Therapy | Post-Operative Nausea | Nausea 2nd 24 hours | 3 Participants |
Comparison: Nausea 1st 12 hours for Ketamine Therapy vs Standard Therapyp-value: 0.7298Chi-squared
Comparison: Nausea 2nd 12 hours for Ketamine Therapy vs Standard Therapyp-value: 0.1058Chi-squared
Comparison: Nausea 2nd 24 hours for Ketamine Therapy vs Standard Therapyp-value: 1Chi-squared