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The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.
The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-free General Anesthesia (OFA) | Experimental | Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. |
|
| Traditional Opioid-containing General Anesthesia (TOA) | Active Comparator | Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen, Gabapentin | Drug | 975 mg, 300 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first flatus | Time between the end of surgery and the movement when the patient first passes flatus | End of surgery to first flatus (1-4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first defecation | Time between the end of surgery and the moment the patient first passes stool | End of surgery to first defecation (1-7 days) |
| Time to tolerance of oral intake | Time between the end of surgery to when the patient can tolerate any oral solid food intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Gamble, MD | Contact | 306-655-1183 | jonathan.gamble@saskhealthauthority.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal University Hospital | Recruiting | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| Acetaminophen, Gabapentin | Drug | 975 mg, 300 mg |
|
|
| Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine | Drug | 1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg |
|
|
| Dexamethasone, Ondansetron | Drug | 6 mg, 4 mg |
|
|
| Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate | Drug | Dose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes |
|
|
| Lidocaine 1% Injectable Solution, Sufentanil | Drug | 0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect) |
|
|
| Sevoflurane, Sufentanil | Drug | Dose titrated to effect, As needed (dose at anesthesiologist's discretion) |
|
|
| End of surgery to first oral intake (1-3 days) |
| Total Post-Anesthetic Care Unit (PACU) opioid consumption | Total amount of opioid (morphine equivalents) required in PACU | End of surgery to discharge from PACU (1-2 hours) |
| Patient Controlled Analgesia (PCA) morphine consumption | Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively | End of surgery to 48 hours postoperatively |
| Time to Post-Anesthetic Care Unit (PACU) discharge readiness | Time to Post-Anesthetic Care Unit (PACU) discharge readiness | End of surgery to PACU discharge readiness (1-3 hours) |
| Visual Analogue Scale (VAS) pain scores | Visual Analogue Scale (VAS) pain scores will be recorded on a scale of 0 to 10, with 0 indicating no pain, and 10 indicating extreme pain, 48 hours following surgery | End of surgery to 48 hours postoperatively |
| Quality of recovery after surgery | Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery | End of surgery to time of patient discharge from hospital (2-10 days) |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077206 | Gabapentin |
| D008012 | Lidocaine |
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| D003907 | Dexamethasone |
| D017294 | Ondansetron |
| D000077149 | Sevoflurane |
| D008278 | Magnesium Sulfate |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
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