Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT06966102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-11
First Post:
2025-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lidocaine Infusion Versus Magnesium Infusion in Decreasing Fentanyl Requirements in Endoscopic Sinus Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-03', 'studyFirstSubmitDate': '2025-05-03', 'studyFirstSubmitQcDate': '2025-05-03', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative fentanyl consumption', 'timeFrame': 'for 5 hours starting from induction of general anesthesia', 'description': 'total fentanyl consumption during surgery'}], 'secondaryOutcomes': [{'measure': 'intraoperative mean arterial blood pressure', 'timeFrame': 'for 5 hours starting from induction of general anesthesia', 'description': 'mean arterial blood pressure during surgery'}, {'measure': 'Intraoperative heart rate', 'timeFrame': 'for 5 hours starting from induction of general anesthesia', 'description': 'heart rate during surgery'}, {'measure': 'Clarity of the surgical field', 'timeFrame': 'for 5 hours starting from induction of general anesthesia', 'description': 'Clarity of the surgical field according to Fromme and Boezaart scale (grade 0 means no bleeding and grade 5 means High bleeding, so constant blood evacuation is needed)'}, {'measure': 'Surgeon satisfaction', 'timeFrame': 'for 5 hours starting from induction of general anesthesia', 'description': 'Surgeon satisfaction assessed at the end of the operation on a 5-point Likert satisfaction scale (grade 1 means Extremely dissatisfied and grade 5 means Extremely satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enhanced Recovery', 'Functional Endoscopic Sinus Surgery', 'Lidocaine', 'Magnesium Sulphate', 'Perioperative Pain']}, 'descriptionModule': {'briefSummary': 'Enhanced recovery after ear, nose and throat surgery is based on multimodal and multidisciplinary perioperative interventions to decrease postoperative pain. Functional endoscopic sinus surgery is a surgical management for chronic rhinosinusitis. Although a common procedure, there is a lack of knowledge about perioperative pain and specific pain management after such a procedure. Most of recommendations given in guidelines for postoperative pain management in nasal surgery and sinus surgery are subsumed under head and neck surgery. Head and neck surgery is a wide field covering widely variable surgical procedures. So, postoperative pain management guidelines may not meet the requirements for pain management during and after endoscopic sinus surgery.\n\nVarious medications have been used to improve the surgical field and postoperative pain including intravenous clonidine, dexmedetomidine, lidocaine, and magnesium.\n\nLidocaine has been used considering its analgesic, immuno-modulating, and anti-inflammatory properties. The opioid sparing effect of lidocaine is supported by a high level of evidence. The effectiveness of lidocaine infusion in obtaining reduction of postoperative pain, gastrointestinal recovery time, postoperative nausea and vomiting, and shortening the hospital length of stay, was demonstrated principally in major gastro-intestinal surgery.\n\nMagnesium sulfate is a good option in multimodal analgesia, as it stabilizes the cell membrane and intracytoplasmic organelles by mediating the activation of Na+-K+ ATPase and Ca++ ATPase enzymes, which have an important role in transmembrane ion exchange during the depolarization and repolarization phases. Moreover, magnesium inhibits the release of norepinephrine by blocking the N-type Ca++ channels at nerve endings.\n\nMany studies were designed to prove the role of the analgesic effect of lidocaine and magnesium infusion. However, this is the first randomized controlled study to assess the effect of lidocaine infusion versus magnesium sulphate infusion on decreasing total fentanyl requirements in patients undergoing functional endoscopic sinus surgery.\n\nThis randomized controlled trial was designed to compare the efficacy of lidocaine hydrochloride infusion versus magnesium sulphate infusion in controlling perioperative pain in patients undergoing functional endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 21 to 60 years.\n* Both genders.\n* American society of Anesthesiologist (ASA) physical status I-II\n* Scheduled for functional endoscopic sinus surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Patients with prolonged QT interval.\n* Patients with renal disease.\n* Patients with a history of allergy to lidocaine or magnesium sulfate.\n* American Society of Anesthesiologists class higher than II.\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT06966102', 'briefTitle': 'Lidocaine Infusion Versus Magnesium Infusion in Decreasing Fentanyl Requirements in Endoscopic Sinus Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluating the Effect of Lidocaine Infusion Versus Magnesium Sulfate Infusion on Decreasing Total Fentanyl Requirements in Patients Undergoing Functional Endoscopic Sinus Surgeries: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MS-15-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group L', 'description': 'Patients received 2 mg/kg/h lidocaine hydrocloride starting at induction of anesthesia and continuing until the end of surgery', 'interventionNames': ['Drug: Lidocaine group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group M', 'description': 'Patients received magnesium sulphate 20 mg/kg/h starting at induction of anesthesia and continuing until the end of surgery', 'interventionNames': ['Drug: Magnesium group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group C', 'description': 'Patients received saline infusion starting at induction of anesthesia and continuing until the end of surgery', 'interventionNames': ['Drug: Control group']}], 'interventions': [{'name': 'Lidocaine group', 'type': 'DRUG', 'description': '25ml of lidocaine hydrochloride 2% will be added to 25 ml of standard saline 0.9% solution in a 50ml syringe to be infused via a syringe pump. The resultant concentration will be 10mg/ml. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h', 'armGroupLabels': ['Group L']}, {'name': 'Magnesium group', 'type': 'DRUG', 'description': 'a 50ml syringe will be filled with magnesium sulfate solution (100mg/ml) to be infused via a syringe pump. According to the calculated study drug dose, each patient will receive 0.2ml/kg/h', 'armGroupLabels': ['Group M']}, {'name': 'Control group', 'type': 'DRUG', 'description': 'a 50ml syringe will be filled with a standard saline 0.9% solution to be infused via a syringe pump. Each patient will receive 0.2ml/kg/h', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Kareem MA Nawwar, M.D.', 'role': 'CONTACT', 'email': 'drknawwar@cu.edu.eg', 'phone': '+201003878369'}], 'overallOfficials': [{'name': 'Jehan Elkholy, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}, {'name': 'Kareem MA Nawwar, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Dina M Mohamed, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Dalia G Abdel Nasser, M.B.B.Ch.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Kareem Mohammed Assem Nawwar', 'investigatorAffiliation': 'Cairo University'}}}}