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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intraoperative infusion of ketamine |
|
| Control | Placebo Comparator | Control group receiving a saline infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline Flush, 0.9% Injectable Solution_#1 | Drug | Normal saline infusion mimicking infusion rate of ketamine for a given weight |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Opioids Used in the First 48 Hours Postoperatively | Opioids used, in Dilaudid equivalents | First 48 hours after arrival to the ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Opioids Used | Quantity in mg | 24 hours postoperatively |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Cameron, MD | Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | H3T1E2 | Canada |
Will provide all uncoded data
Upon request, starting 6 months after publication
For planned meta-analyses
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery) |
| FG001 | Control | Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketamine | Bolus 0.5mg/kg, Infusion 0.5mg/kg/hr |
| BG001 | Placebo | Normal Saline 0.025cc/kg bolus, 0.025cc/kg/hr |
| 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 | Quantity of Opioids Used in the First 48 Hours Postoperatively | Opioids used, in Dilaudid equivalents | Posted | Mean | 95% Confidence Interval | mg of Dilaudid | First 48 hours after arrival to the ICU |
|
1 year, 6 months
No noted adverse events
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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 | Intraoperative infusion of ketamine Ketamine Hydrochloride: Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Matthew Cameron | Jewish General Hospital | 514-340-8222 | 25701 | matthew.cameron@mcgill.ca |
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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 | Aug 23, 2017 | Jun 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine Hydrochloride | Drug | Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery) |
|
| Postoperative days 2 |
| Postoperative Nausea and Vomiting | Whether or not the patient suffered from nausea and vomiting after surgery which required treatment | 48 hours after ICU arrival |
| Intensive Care Unit Length of Stay | Number of days spent in the intensive care unit | 1 day - 2 weeks |
| Hospital Length of Stay | number of days spent in the hospital, starting from the day of surgery | 5 days - 2 weeks |
| Time to Extubation | Number of minutes from the time of ICU arrival to extubation | 4 hours - 2 weeks |
| Delirium | Delirium as assessed by a positive CAM-ICU score during the ICU stay | ICU stay |
| Time to Mobilization | Time from ICU arrival until patient able to mobilize to chair, measured in hours | During hospital stay |
| Time to Ambulation | Time from ICU arrival until patient able to ambulate, measured in hours | 1 week postoperatively |
| BG002 |
| 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 | Count of Participants | Participants |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Cardiopulmonary Bypass time (mins) | Mean | Standard Deviation | mins |
|
| Cross Clamp Time (mins) | Mean | Standard Deviation | minutes |
|
| Intraoperative Sufentanil per kg | Mean | Standard Deviation | mcg/kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Quantity of Opioids Used | Quantity in mg | Posted | Mean | 95% Confidence Interval | mg of Dilaudid | 24 hours postoperatively |
|
|
|
| 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) | Posted | Median | Inter-Quartile Range | score on a scale | Postoperative days 2 |
|
|
|
| Secondary | Postoperative Nausea and Vomiting | Whether or not the patient suffered from nausea and vomiting after surgery which required treatment | Posted | Count of Participants | Participants | 48 hours after ICU arrival |
|
|
|
| Secondary | Intensive Care Unit Length of Stay | Number of days spent in the intensive care unit | Posted | Median | Inter-Quartile Range | days | 1 day - 2 weeks |
|
|
|
| Secondary | Hospital Length of Stay | number of days spent in the hospital, starting from the day of surgery | Posted | Median | Inter-Quartile Range | days | 5 days - 2 weeks |
|
|
|
| Secondary | Time to Extubation | Number of minutes from the time of ICU arrival to extubation | Posted | Mean | 95% Confidence Interval | minutes | 4 hours - 2 weeks |
|
|
|
| Secondary | Delirium | Delirium as assessed by a positive CAM-ICU score during the ICU stay | Posted | Count of Participants | Participants | ICU stay |
|
|
|
| Secondary | Time to Mobilization | Time from ICU arrival until patient able to mobilize to chair, measured in hours | Posted | Mean | 95% Confidence Interval | hours | During hospital stay |
|
|
|
| Secondary | Time to Ambulation | Time from ICU arrival until patient able to ambulate, measured in hours | Posted | Mean | 95% Confidence Interval | hours | 1 week postoperatively |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Placebo | Control group receiving a saline infusion Normal Saline Flush, 0.9% Injectable Solution_#1: Normal saline infusion mimicking infusion rate of ketamine for a given weight | 0 | 38 | 0 | 38 | 0 | 38 |
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| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |