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recruitment failure
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The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.
Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate |
|
| Ketamine low-dose | Active Comparator | Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min |
|
| Ketamine high-dose | Active Comparator | Loading: 1 mg/Kg Infusion: 10 mcg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Opioid Consumption | Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing "no pain" and 10 "very much pain. | one day |
| Participants With Nausea and Vomiting at PACU |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Roya Yumul, MD., PhD | Cedars-Sinai Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate |
| FG001 | Ketamine Low-dose | Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min |
| FG002 | Ketamine High-dose | Loading: 1 mg/Kg Infusion: 10 mcg/kg/min |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate |
| BG001 | Ketamine Low-dose | Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min |
| 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 | Number of Participants With Opioid Consumption | Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts | Posted | Number | participants | 1 day |
|
one month
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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 | Control | Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research project Advisor | Cedars Sinai Medical Center | 310-423-1682 | Ofelia.Elvir-Lazo@cshs.org |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D003248 | Constipation |
| D045823 | Ileus |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Ketamine high-dose | Drug | Loading: 1 mg/Kg Infusion: 10 mcg/kg/min |
|
| Ketamine low-dose | Drug | Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min |
|
Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
| 1 day |
| BG002 | Ketamine High-dose | Loading: 1 mg/Kg Infusion: 10 mcg/kg/min |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
|
|
| Secondary | Postoperative Pain | Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing "no pain" and 10 "very much pain. | Posted | Mean | Standard Deviation | Score on scale | one day |
|
|
|
| Secondary | Participants With Nausea and Vomiting at PACU | Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Ketamine Low-dose | Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Ketamine High-dose | Loading: 1 mg/Kg Infusion: 10 mcg/kg/min | 0 | 7 | 0 | 7 | 0 | 7 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |