Nctid:
NCT06613893
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type 2 Diabetes", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes Mellitus", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000005283", "term"=>"Fentanyl"}], "ancestors"=>[{"id"=>"D000000777", "term"=>"Anesthetics"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000701", "term"=>"Analgesics, Opioid"}, {"id"=>"D000009294", "term"=>"Narcotics"}, {"id"=>"D000000700", "term"=>"Analgesics"}, {"id"=>"D000018689", "term"=>"Sensory System Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000000759", "term"=>"Adjuvants, Anesthesia"}, {"id"=>"D000018686", "term"=>"Anesthetics, Intravenous"}, {"id"=>"D000018681", "term"=>"Anesthetics, General"}], "browseLeaves"=>[{"id"=>"M18307", "name"=>"Propofol", "relevance"=>"LOW"}, {"id"=>"M10562", "name"=>"Isoflurane", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M8418", "name"=>"Fentanyl", "asFound"=>"Magnetic", "relevance"=>"HIGH"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"M16802", "name"=>"Tolnaftate", "relevance"=>"LOW"}, {"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M12245", "name"=>"Narcotics", "relevance"=>"LOW"}, {"id"=>"M4089", "name"=>"Adjuvants, Anesthesia", "relevance"=>"LOW"}, {"id"=>"M20766", "name"=>"Anesthetics, Intravenous", "relevance"=>"LOW"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Adjuvants, Anesthesia", "abbrev"=>"AdjAn"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>42}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-02-28", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-06", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Blood glucose levels in milligrams per decilitre (mg/dl) at different time points", "timeFrame"=>"Immediate preoperative till 48 hours after recovery from anesthesia", "description"=>"Blood glucose levels in milligrams per deciliter at different time points: preoperative (T0), post-intubation (T1), 1st , 2nd and 3rd hour after the start of the operation (T3, T4 and T5, respectively), 1st hour after the operation (T6) , 2nd hour after the operation (T7), 1st and 2nd day after the operation (T8, T9)"}], "secondaryOutcomes"=>[{"measure"=>"Serum insulin level in picomoles per litre (pmol/l)", "timeFrame"=>"30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia", "description"=>"serum insulin level (pmol/l) 30 min before and 30 min after surgery"}, {"measure"=>"Serum cortisol level in micrograms per decilitre (mcg/dl)", "timeFrame"=>"30 min before induction of anesthesia and 30 min after surgery and recovery from anesthesia", "description"=>"serum cortisol level (mcg/dl) 30 min before and 30 min after surgery"}, {"measure"=>"The incidence of postoperative complications", "timeFrame"=>"The complications will be assessed on the first, third and seveth post-operative day", "description"=>"The complications that will be tested Acute coronary syndrome. Stroke. acute kidney injury. stress gastric ulcer. surgical site infection. Hypoglycaemia (blood glucose level below 70 mg/dL). Hyperglycemia (fasting blood glucose level greater than 125mg/dL while 2 hours postprandial greater than 200 mg/dL).\n\nPostoperative nausea and vomiting . postoperative pulmonary complications including atelectasis, pneumonia and respiratory failure"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Type 2 Diabetes Mellitus (T2DM)", "Thoracic Surgery"]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study is to compare the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia (IHA) as maintenance anesthesia on blood glucose level and complications in type 2 diabetic patients undergoing thoracic surgery . All participants had to understand and give written informed consent , and ethical committee approval (of Faculty of Medicine, Ain Shams University) will be obtained before participants allocation.", "detailedDescription"=>"* Type of Study: prospective , randomized .\n* Study Settings: Ain Shams University hospitals, Cairo, Egypt.\n* Study period: 12 months starting from janurary 2024 .\n* Study Population: All adult type 2 diabetic patients (30-70 year old) with class II,III based on the American Society of Anesthesiologists (ASA) physical status undergoing elective thoracic surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes:\n\n 1. Group A will receive total inravenous anesthesia (TIVA).\n 2. Group B will receive inhalational anesthesia (IHA)"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age 30 - 70 years\n* Sex: Both sexes\n* Patients with type 2 diabetes mellitus controlled with oral hypoglycemic drugs\n* Patients with ASA classification II,III\n* Duration of surgery (≥2 h)\n\nExclusion Criteria:\n\n* Declining to give written informed consent\n* ASA classification Ⅳ to V\n* Severe systemic diseases\n* Metabolic disorders, diabetic ketoacidosis or hyperglycemia (fasting blood Glucose more than 140 mg/dl)\n* Hepatic and/or renal dysfunction\n* Neuromuscular disease\n* Pancreatic cancer\n* History of malignant hyperthermia\n* Emergency surgery\n* Ischemic heart disease and valvular heart disease\n* Body mass index more than 40\n* Diabetic patients on insulin therapy"}, "identificationModule"=>{"nctId"=>"NCT06613893", "briefTitle"=>"Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose in Type 2 Diabetes Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Ain Shams University"}, "officialTitle"=>"Effect of Inhalational Anesthesia Versus Total Intravenous Anesthesia on Blood Glucose Level in Type 2 Diabetes Mellitus Patients Undergoing Thoracic Surgery : a Comparative Study", "orgStudyIdInfo"=>{"id"=>"FMASU@MD331/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Group A will receive total inravenous anesthesia (TIVA)", "description"=>"patients in this group will receive total intravenous anesthesia using propofol infusion after induction of anesthesia, tested variables will be measured according to the protocol", "interventionNames"=>["Drug: TIVA"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group B will receive inhalational anesthesia (IHA)", "description"=>"patients in this group will receive inhalational anesthesia using isoflurane after induction of anesthesia, tested variables will be measured according to the protocol", "interventionNames"=>["Drug: Inhalational anesthesia"]}], "interventions"=>[{"name"=>"TIVA", "type"=>"DRUG", "otherNames"=>["Fentanyl"], "description"=>"Anesthesia will be maintained by total intravenous anesthesia with propofol infusion (4 to 12 mg/kg/min) and fentanyl infusion (3-4.8 mic /kg/hour)(Ting 2019) that will be stopped 30 min before the end of the operation ,The heart rate and blood pressure will be maintained within the range of ±20% of the baseline", "armGroupLabels"=>["Group A will receive total inravenous anesthesia (TIVA)"]}, {"name"=>"Inhalational anesthesia", "type"=>"DRUG", "description"=>"Anesthesia will be maintained with inhaled isoflurane from (0.7 to 1.4%)(Hawkley, Preston, and Maani 2018) and fentanyl 0.35 to 0.5 mcg/kg supplementary dose will be given if needed to maintain the heart rate and blood pressure within the range of ±20% of the baseline", "armGroupLabels"=>["Group B will receive inhalational anesthesia (IHA)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Cairo", "country"=>"Egypt", "contacts"=>[{"name"=>"Yasser Alaa", "role"=>"CONTACT", "email"=>"yasseralaaismail11@gmail.com"}], "facility"=>"Ain Shams University", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"Yasser A Ismail", "role"=>"CONTACT", "email"=>"yasseralaaismail11@gmail.com", "phone"=>"+021006764485"}], "overallOfficials"=>[{"name"=>"Nabila M Abdelaziz, professor", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Ain Shams University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ain Shams University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator", "investigatorFullName"=>"Yasser Alaa Abdalmonim", "investigatorAffiliation"=>"Ain Shams University"}}}}
