Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2026-03-28 @ 9:59 AM
Study NCT ID:
NCT04078659
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D001279', 'term': 'Atracurium'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}], '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': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-02', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-09-02', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial blood pressure (MAP)', 'timeFrame': '15 minutes after the induction of the hypotensive agent', 'description': 'automatically non invasive measured every 3 minutes , recorded every 15 minutes till the end and 15 minutes after extubation the end and 15 minutes after extubation'}], 'secondaryOutcomes': [{'measure': 'The blood loss', 'timeFrame': 'at the end of the surgery', 'description': 'The blood loss would be calculated using the following formula Blood Loss = Blood Volume. In )Hct 1 / Hct2)'}, {'measure': 'The number of patients will need nitroglycerine and dose', 'timeFrame': 'at the end of the surgery', 'description': 'The number of patients will need nitroglycerine'}, {'measure': 'Use of Ephedrine', 'timeFrame': 'at the end of the surgery', 'description': 'The number of patients will need ephedrine'}, {'measure': 'Need for blood transfusion', 'timeFrame': 'at the end of the surgery', 'description': 'The number of patient need for blood transfusion'}, {'measure': 'Postoperative Ramsey sedation', 'timeFrame': 'for the first hour postoperative', 'description': 'patient awake, anxious, agitated or restless 2 patient awake -1co operative, oriented and tranquil 3 patient drowsy with respond to command 4 patient asleep brisk response to glabella tap or loud auditory sound 5 patient asleep with sluggish response to stimulus 6 patient hasno response to nail bed pressure or othernoxious stimuli'}, {'measure': 'Simplified post operative nausea and vomiting score', 'timeFrame': 'for the first 24 hour postoperative', 'description': 'using impact scale score evaluation'}, {'measure': 'Recovery time', 'timeFrame': 'one hour after extubation', 'description': 'time needed to reach modified aldrete score\\> or=9)'}, {'measure': 'Heart rate (HR)', 'timeFrame': '15 minutes after the start of the hypotensive agent'}, {'measure': 'surgical field assessment', 'timeFrame': '2 hours intraoperative', 'description': 'By the surgeon interms of bleeding and visibility using a 6-option Liker-scale scale adapted from Fromme el al. (26): 0 = no bleeding; 1 = minor bleeding, but no aspiration required; 2 = minor bleeding, aspiration required; 3 = minor bleeding, frequent aspiration required; 4 = moderate bleeding, visible� only with aspiration; 5 = severe bleeding, continuous aspiration required'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopic Sinus Surgery']}, 'descriptionModule': {'briefSummary': 'Endoscopic Sinus surgery usually associated by bleeding, despite using of local vasopressor injection, head up position- controlled hypotension is generally used for control of this purpose.\n\nPropofol has been reported as a good agent for controlled hypotension by decreasing systemic vascular resistance secondary to arterial and venous vasodilation and a decrease in myocardial contractility with a dose-dependent property.\n\nMagnesium Sulfate also has been reported as an agent of hypotensive anaesthesia by inhibition of the release of norepinephrine by blocking N-type calcium channel at the nerve ending beside acting as a vasodilator.\n\nThe well known pharmacodynamic effects of the intravenous infusion of propofol or Magnesium Sulfate may prove the advantage of this group in controlling intraoperative blood pressure thus reducing surgical field bleeding.', 'detailedDescription': 'The aim of the work to compare the efficacy of propofol and magnesium sulfate to control blood pressure during endoscopic sinus surgery and the resultant effects on the quality of the surgical field including bleeding and visibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists Physical Classes I or II\n\nExclusion Criteria:\n\n* Patients refusal\n* Patients with hypersensitivity for any drug used in the study including magnesium, propofol or isoflurane\n* Patients receiving magnesium sulfate supplementation\n* Patients receiving drugs known to have significant interaction.\n* Patients with ischemic heart disease\n* Patients with heart defects\n* Patients with significant heart failure\n* Patients with increased intracranial pressure.\n* Patients with systemic hypertension'}, 'identificationModule': {'nctId': 'NCT04078659', 'briefTitle': 'Propofol and Magnesium Sulfate Intravenous Infusion During Endoscopic Sinus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Controlled Hypotension During Endoscopic Sinus Surgery: A Comparison of Propofol and Magnesium Sulfate', 'orgStudyIdInfo': {'id': 'MS ∕18.08.247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol infusion', 'description': 'Patients received intravenous Propofol infusion', 'interventionNames': ['Drug: Propofol infusion', 'Drug: Lidocaine', 'Drug: Fentanyl', 'Drug: Propofol', 'Drug: Atracurium', 'Procedure: Mechanical Ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'Magnesium Sulfate infusion', 'description': 'Patients received intravenous Magnesium Sulfate infusion', 'interventionNames': ['Drug: Magnesium Sulfate infusion', 'Drug: Lidocaine', 'Drug: Fentanyl', 'Drug: Propofol', 'Drug: Atracurium', 'Procedure: Mechanical Ventilation']}], 'interventions': [{'name': 'Propofol infusion', 'type': 'DRUG', 'description': 'Following induction of anaesthesia, propofol infusion will be started 75 mcg/kg/min for the first 10-15 minutes, then a maintenance infusion of propofol (50 mcg/kg /min)', 'armGroupLabels': ['Propofol infusion']}, {'name': 'Magnesium Sulfate infusion', 'type': 'DRUG', 'description': 'Before induction of anaesthesia, Magnesium Sulfate infusion will be started at 40 mg/kg in 100 ml saline over 10 minutes as the loading dose then Magnesium sulfate infusion 10-15 mg/kg/hr started immediately after induction of anaesthesia', 'armGroupLabels': ['Magnesium Sulfate infusion']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia', 'armGroupLabels': ['Magnesium Sulfate infusion', 'Propofol infusion']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia', 'armGroupLabels': ['Magnesium Sulfate infusion', 'Propofol infusion']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Patients will receive propofol in a dose of 1-2 mg /kg', 'armGroupLabels': ['Magnesium Sulfate infusion', 'Propofol infusion']}, {'name': 'Atracurium', 'type': 'DRUG', 'description': 'Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation', 'armGroupLabels': ['Magnesium Sulfate infusion', 'Propofol infusion']}, {'name': 'Mechanical Ventilation', 'type': 'PROCEDURE', 'description': 'Patients lungs will be ventilated using the volume controlled mechanically ventilated with 40% oxygen in the air with positive end-expiratory pressure (PEEP) of 5 cmH2O, tidal volume 500 ml and Respiratory Rate of 12 per minute', 'armGroupLabels': ['Magnesium Sulfate infusion', 'Propofol infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'contacts': [{'name': 'Nabil A Abd El-Mageed, MD', 'role': 'CONTACT', 'email': 'nabil-abdelraouf@yahoo.com', 'phone': '00201001538648', 'phoneExt': '00201001538648'}, {'name': 'Hazem E Meawad, MD', 'role': 'CONTACT', 'email': 'hazemmoawad@yahoo.com', 'phone': '00201121516041'}, {'name': 'Maha A Abo-Zeid, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohamed E Mohamed, M.Sec', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nabil A Abd El-Mageed', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Nabil A Abd El-Mageed, MD', 'role': 'CONTACT', 'email': 'nabil-abdelraouf@yahoo.com', 'phone': '00201001538648', 'phoneExt': '00201121516041'}, {'name': 'Hazem E Moawed, MD', 'role': 'CONTACT', 'email': 'hazemmoawad@yahoo.com', 'phone': '00201121516041', 'phoneExt': '00201121516041'}], 'overallOfficials': [{'name': 'Hazem E Moawed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Anesthesia and Surgical Intensive Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}