Pain, Postoperative
Conditions
Keywords
Ketamine, Cardiac surgery, Pain
Brief summary
Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.
Detailed description
This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome
Interventions
Normal saline infusion mimicking infusion rate of ketamine for a given weight
DRUGKetamine Hydrochloride
Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
Sponsors
Jewish General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery
Exclusion criteria
* Minimally invasive cardiac surgery * Preoperative opioid use * Preoperative hepatic or renal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Opioids Used in the First 48 Hours Postoperatively | First 48 hours after arrival to the ICU | Opioids used, in Dilaudid equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (Visual Analog Scale) | Postoperative days 2 | Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable) |
| Postoperative Nausea and Vomiting | 48 hours after ICU arrival | Whether or not the patient suffered from nausea and vomiting after surgery which required treatment |
| Intensive Care Unit Length of Stay | 1 day - 2 weeks | Number of days spent in the intensive care unit |
| Hospital Length of Stay | 5 days - 2 weeks | number of days spent in the hospital, starting from the day of surgery |
| Quantity of Opioids Used | 24 hours postoperatively | Quantity in mg |
| Delirium | ICU stay | Delirium as assessed by a positive CAM-ICU score during the ICU stay |
| Time to Mobilization | During hospital stay | Time from ICU arrival until patient able to mobilize to chair, measured in hours |
| Time to Ambulation | 1 week postoperatively | Time from ICU arrival until patient able to ambulate, measured in hours |
| Time to Extubation | 4 hours - 2 weeks | Number of minutes from the time of ICU arrival to extubation |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Bolus 0.5mg/kg, Infusion 0.5mg/kg/hr | 42 |
| Placebo Normal Saline 0.025cc/kg bolus, 0.025cc/kg/hr | 38 |
| Total | 80 |
Baseline characteristics
| Characteristic | Ketamine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 9.6 | 67.1 years STANDARD_DEVIATION 8.6 | 66.5 years STANDARD_DEVIATION 9.1 |
| Body Mass Index (kg/m^2) | 29.0 kg/m^2 STANDARD_DEVIATION 4.2 | 28.0 kg/m^2 STANDARD_DEVIATION 4 | 28.5 kg/m^2 STANDARD_DEVIATION 4.1 |
| Cardiopulmonary Bypass time (mins) | 105.4 mins STANDARD_DEVIATION 33.7 | 108.2 mins STANDARD_DEVIATION 29.6 | 106.7 mins STANDARD_DEVIATION 31.5 |
| Cross Clamp Time (mins) | 83.6 minutes STANDARD_DEVIATION 33.4 | 82.7 minutes STANDARD_DEVIATION 25.6 | 83.6 minutes STANDARD_DEVIATION 33.4 |
| Intraoperative Sufentanil per kg | 2.17 mcg/kg STANDARD_DEVIATION 1.11 | 1.96 mcg/kg STANDARD_DEVIATION 0.86 | 2.07 mcg/kg STANDARD_DEVIATION 1.07 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 42 Participants | 38 Participants | 80 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 38 Participants | 33 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 38 |
| other Total, other adverse events | 0 / 42 | 0 / 38 |
| serious Total, serious adverse events | 0 / 42 | 0 / 38 |
Outcome results
Primary
Quantity of Opioids Used in the First 48 Hours Postoperatively
Opioids used, in Dilaudid equivalents
Time frame: First 48 hours after arrival to the ICU
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Quantity of Opioids Used in the First 48 Hours Postoperatively | 10.71 mg of Dilaudid |
| Placebo | Quantity of Opioids Used in the First 48 Hours Postoperatively | 11.14 mg of Dilaudid |
Secondary
Delirium
Delirium as assessed by a positive CAM-ICU score during the ICU stay
Time frame: ICU stay
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine | Delirium | 11 Participants |
| Placebo | Delirium | 7 Participants |
Secondary
Hospital Length of Stay
number of days spent in the hospital, starting from the day of surgery
Time frame: 5 days - 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine | Hospital Length of Stay | 8 days |
| Placebo | Hospital Length of Stay | 7 days |
Secondary
Intensive Care Unit Length of Stay
Number of days spent in the intensive care unit
Time frame: 1 day - 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine | Intensive Care Unit Length of Stay | 1 days |
| Placebo | Intensive Care Unit Length of Stay | 2 days |
Secondary
Pain Scores (Visual Analog Scale)
Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)
Time frame: Postoperative days 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ketamine | Pain Scores (Visual Analog Scale) | 2 score on a scale |
| Placebo | Pain Scores (Visual Analog Scale) | 2 score on a scale |
Secondary
Postoperative Nausea and Vomiting
Whether or not the patient suffered from nausea and vomiting after surgery which required treatment
Time frame: 48 hours after ICU arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine | Postoperative Nausea and Vomiting | 3 Participants |
| Placebo | Postoperative Nausea and Vomiting | 2 Participants |
Secondary
Quantity of Opioids Used
Quantity in mg
Time frame: 24 hours postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Quantity of Opioids Used | 6.5 mg of Dilaudid |
| Placebo | Quantity of Opioids Used | 6.7 mg of Dilaudid |
Secondary
Time to Ambulation
Time from ICU arrival until patient able to ambulate, measured in hours
Time frame: 1 week postoperatively
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Time to Ambulation | 63 hours |
| Placebo | Time to Ambulation | 56 hours |
Secondary
Time to Extubation
Number of minutes from the time of ICU arrival to extubation
Time frame: 4 hours - 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Time to Extubation | 539 minutes |
| Placebo | Time to Extubation | 494 minutes |
Secondary
Time to Mobilization
Time from ICU arrival until patient able to mobilize to chair, measured in hours
Time frame: During hospital stay
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine | Time to Mobilization | 32 hours |
| Placebo | Time to Mobilization | 23 hours |