Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 6:53 PM
Study NCT ID:
NCT04144933
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2019-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D007649', 'term': 'Ketamine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D008278', 'term': 'Magnesium Sulfate'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2019-10-25', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first flatus', 'timeFrame': 'End of surgery to first flatus (1-4 days)', 'description': 'Time between the end of surgery and the movement when the patient first passes flatus'}], 'secondaryOutcomes': [{'measure': 'Time to first defecation', 'timeFrame': 'End of surgery to first defecation (1-7 days)', 'description': 'Time between the end of surgery and the moment the patient first passes stool'}, {'measure': 'Time to tolerance of oral intake', 'timeFrame': 'End of surgery to first oral intake (1-3 days)', 'description': 'Time between the end of surgery to when the patient can tolerate any oral solid food intake'}, {'measure': 'Total Post-Anesthetic Care Unit (PACU) opioid consumption', 'timeFrame': 'End of surgery to discharge from PACU (1-2 hours)', 'description': 'Total amount of opioid (morphine equivalents) required in PACU'}, {'measure': 'Patient Controlled Analgesia (PCA) morphine consumption', 'timeFrame': 'End of surgery to 48 hours postoperatively', 'description': 'Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively'}, {'measure': 'Time to Post-Anesthetic Care Unit (PACU) discharge readiness', 'timeFrame': 'End of surgery to PACU discharge readiness (1-3 hours)', 'description': 'Time to Post-Anesthetic Care Unit (PACU) discharge readiness'}, {'measure': 'Visual Analogue Scale (VAS) pain scores', 'timeFrame': 'End of surgery to 48 hours postoperatively', 'description': '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'}, {'measure': 'Quality of recovery after surgery', 'timeFrame': 'End of surgery to time of patient discharge from hospital (2-10 days)', 'description': 'Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid-free', 'Opioid-sparing'], 'conditions': ['Anesthesia', 'General Anesthesia', 'Analgesics, Opioid', 'Opioid Free Anesthesia', 'Postoperative Ileus', 'Colorectal Surgery', 'Laparoscopic Surgery', 'Analgesia', 'Dexmedetomidine', 'Lidocaine', 'Ketamine']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery\n\nExclusion Criteria:\n\n* Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age \\< 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)'}, 'identificationModule': {'nctId': 'NCT04144933', 'acronym': 'RUMBLE', 'briefTitle': 'Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery', 'orgStudyIdInfo': {'id': 'BIO-625'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opioid-free General Anesthesia (OFA)', 'description': 'Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis.', 'interventionNames': ['Drug: Acetaminophen, Gabapentin', 'Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine', 'Drug: Dexamethasone, Ondansetron', 'Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Opioid-containing General Anesthesia (TOA)', 'description': 'Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis.', 'interventionNames': ['Drug: Acetaminophen, Gabapentin', 'Drug: Dexamethasone, Ondansetron', 'Drug: Lidocaine 1% Injectable Solution, Sufentanil', 'Drug: Sevoflurane, Sufentanil']}], 'interventions': [{'name': 'Acetaminophen, Gabapentin', 'type': 'DRUG', 'otherNames': ['Opioid-free preoperative medications'], 'description': '975 mg, 300 mg', 'armGroupLabels': ['Opioid-free General Anesthesia (OFA)']}, {'name': 'Acetaminophen, Gabapentin', 'type': 'DRUG', 'otherNames': ['Opioid-containing preoperative medications'], 'description': '975 mg, 300 mg', 'armGroupLabels': ['Traditional Opioid-containing General Anesthesia (TOA)']}, {'name': 'Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine', 'type': 'DRUG', 'otherNames': ['Opioid-free pre-intubation medications'], 'description': '1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg', 'armGroupLabels': ['Opioid-free General Anesthesia (OFA)']}, {'name': 'Dexamethasone, Ondansetron', 'type': 'DRUG', 'otherNames': ['Postoperative nausea and vomiting prophylaxis'], 'description': '6 mg, 4 mg', 'armGroupLabels': ['Opioid-free General Anesthesia (OFA)', 'Traditional Opioid-containing General Anesthesia (TOA)']}, {'name': 'Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate', 'type': 'DRUG', 'otherNames': ['Opioid-free maintenance medications'], 'description': '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', 'armGroupLabels': ['Opioid-free General Anesthesia (OFA)']}, {'name': 'Lidocaine 1% Injectable Solution, Sufentanil', 'type': 'DRUG', 'otherNames': ['Opioid-containing pre-intubation medications'], 'description': '0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)', 'armGroupLabels': ['Traditional Opioid-containing General Anesthesia (TOA)']}, {'name': 'Sevoflurane, Sufentanil', 'type': 'DRUG', 'otherNames': ['Opioid-containing maintenance medications'], 'description': "Dose titrated to effect, As needed (dose at anesthesiologist's discretion)", 'armGroupLabels': ['Traditional Opioid-containing General Anesthesia (TOA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': "Jennifer O'Brien, PhD", 'role': 'CONTACT', 'email': "jennifer.o'brien@saskatoonhealthregion.ca", 'phone': '306-655-6497'}], 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'centralContacts': [{'name': 'Jonathan Gamble, MD', 'role': 'CONTACT', 'email': 'jonathan.gamble@saskhealthauthority.ca', 'phone': '306-655-1183'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Jonathan Gamble', 'investigatorAffiliation': 'University of Saskatchewan'}}}}