Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-29 @ 6:57 PM
Study NCT ID:
NCT06272461
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intravenous Lidocaine vs intravenous ketamine'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The variation of Interleukin-6 levels', 'timeFrame': '24 hours after surgery', 'description': 'The difference of Interleukine-6 (IL-6) plasma concentration between baseline values and 24 hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Pain assessed by Numerical Rating Scale (NRS)', 'timeFrame': 'Postoperatively, at Hour 2, Hour 12 and Hour 24. the patient asked to circle the number between 0 and 10:"0" usually represents \'no pain at all\' whereas "10" represents \'the worst pain ever possible\'.', 'description': 'Postoperative pain was assessed by the Numerical Rating Scale (NRS)'}, {'measure': 'Post-operative nausea and vomiting', 'timeFrame': 'During the first 24 hours postoperatively', 'description': 'Incidence of post-operative nausea and vomiting during the first 24 hours.'}, {'measure': 'Bowel function.', 'timeFrame': 'During the first 24 hours postoperatively', 'description': 'Time to return of bowel function.'}, {'measure': 'Hospital length of stay.', 'timeFrame': 'From date of randomization until the date of to discharge from the hospital assessed up to 15 days', 'description': 'Hospital length of stay ( in days)'}, {'measure': 'Post-operative complications.', 'timeFrame': 'From date of randomization until the date of to discharge from the hospital assessed up to 15 days', 'description': 'Incidence of intrahospital post-operative complications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal (Colon or Rectal) Cancer', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Patients undergoing open colorectal surgery were randomly divided into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).\n\nFor the IV-Lido group, patients received a loading dose of Lidocaine than a continuous infusion over twenty-four hours.\n\nFor the IV-Keta goup, patients received a loading dose of Ketamine than a continuous injection of Ketamine over twenty-four hours.\n\nPlasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively.', 'detailedDescription': 'Patients undergoing open colorectal surgery with tumor resection were randomised prospectively into two groups: Intravenous Lidocaine (IV-Lido) vs Intravenous Ketamine (IV-Keta).\n\nFor the IV-Lido group (n=25), patients received a loading dose of 1.5 mg/kg of Lidocaine than a continuous infusion of 1.5 mg/kg/h over twenty-four hours.\n\nFor the IV-Keta goup(n=25), patients received a loading dose of 0.15mg/kg of Ketamine than a continuous injection of 0.15 mg/kg/h of Ketamine over twenty-four hours.\n\nFor both groups, plasma concentrations of Interleukin-6(IL-6) were measured preoperatively before anesthetic induction and at twenty-four hour post operatively. Plasma IL-6 concentrations at each point were compared between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n* Patients aged 18 or older.\n* American society of anesthesiologists' (ASA) physical status of I-III.\n* Elective open colorectal surgery.\n\nNON INCLUSION CRITERIA:\n\n* Patients with contraindications to lidocaine or ketamine.\n* Corticosteroid therapy within the last 6 months.\n* History of immunosuppressive therapy.\n* History of surgery in the last 3 months.\n* Personal medical history of inflammatory bowel disease.\n* Personal medical history of cardiac arrythmias or conduction disorders.\n* Alcohol or drug abuse.\n* Chronic use of opioids or benzodiazepines.\n\nEXCLUSION CRITERIA:\n\n* Severe intraoperative complications.\n* Duration of surgery longer than 5 hours."}, 'identificationModule': {'nctId': 'NCT06272461', 'briefTitle': 'Comparison of Intravenous Lidocaine vs Ketamine in Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'The Effect of Intravenous Lidocaine or Ketamine on Interleukin-6 Levels in Patients Undergoing Colorectal Surgery for Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UTEM ELKI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV-Lido', 'description': 'Intravenous Lidocaine dose loading than continuous infusion', 'interventionNames': ['Drug: Lidocaine IV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV-Keta', 'description': 'Intravenous Ketamine dose loading than continuous infusion', 'interventionNames': ['Drug: Ketamine Injectable Solution']}], 'interventions': [{'name': 'Lidocaine IV', 'type': 'DRUG', 'description': 'Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer', 'armGroupLabels': ['IV-Lido']}, {'name': 'Ketamine Injectable Solution', 'type': 'DRUG', 'description': 'Intravenous Lidocaine Vs intravenous Ketamine in colorectal surgery for cancer', 'armGroupLabels': ['IV-Keta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Nabeul', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'BEN ALI MECHAAL', 'role': 'CONTACT', 'email': 'mechaal_benali@yahoo.fr', 'phone': '53890987', 'phoneExt': '00216'}], 'facility': 'Tunisia', 'geoPoint': {'lat': 36.45606, 'lon': 10.73763}}], 'centralContacts': [{'name': 'BEN ALI MECHAAL, Professor', 'role': 'CONTACT', 'email': 'mechaal_benali@yahoo.fr', 'phone': '72100533', 'phoneExt': '00216'}, {'name': 'KTATA HIBA, Dr', 'role': 'CONTACT', 'email': 'Hibetallah.ktata@fmt.utm.tn', 'phone': '72100500', 'phoneExt': '00216'}], 'overallOfficials': [{'name': 'BEN ALI MECHAAL, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'university manar Tunis, Tunisia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'HibetAllah Ktata', 'investigatorAffiliation': 'University Tunis El Manar'}}}}