Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-01-22 @ 10:06 AM
Study NCT ID:
NCT06587620
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of tranexamic acid and dexmedetomidine on improving surgical field quality', 'timeFrame': '240 minuets', 'description': 'The visibility of the surgical field was assessed by surgeon using Boezaart scoring system throughout the operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Field Quality Improvement in Spine Surgeries']}, 'referencesModule': {'references': [{'pmid': '31624738', 'type': 'BACKGROUND', 'citation': 'Yoo JS, Ahn J, Karmarkar SS, Lamoutte EH, Singh K. The use of tranexamic acid in spine surgery. Ann Transl Med. 2019 Sep;7(Suppl 5):S172. doi: 10.21037/atm.2019.05.36.'}, {'pmid': '34030806', 'type': 'BACKGROUND', 'citation': 'Tasbihgou SR, Barends CRM, Absalom AR. The role of dexmedetomidine in neurosurgery. Best Pract Res Clin Anaesthesiol. 2021 Jul;35(2):221-229. doi: 10.1016/j.bpa.2020.10.002. Epub 2020 Oct 14.'}, {'pmid': '31602066', 'type': 'BACKGROUND', 'citation': 'Ruku R, Jamwal A, Bhadrala N, Gulati S. Randomized Open-Labelled Comparative Evaluation of the Efficacy of Nitroglycerine, Esmolol and Dexmedetomidine in Producing Controlled Hypotension in Spine Surgeries. Anesth Essays Res. 2019 Jul-Sep;13(3):486-491. doi: 10.4103/aer.AER_78_19.'}, {'pmid': '31303717', 'type': 'BACKGROUND', 'citation': 'Kundra S, Taneja S, Choudhary AK, Katyal S, Garg I, Roy R. Effect of a low-dose dexmedetomidine infusion on intraoperative hemodynamics, anesthetic requirements and recovery profile in patients undergoing lumbar spine surgery. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):248-253. doi: 10.4103/joacp.JOACP_338_18.'}, {'pmid': '36721414', 'type': 'BACKGROUND', 'citation': 'Ahmadi MS, Jahanshahi J, Hashemian F, Salimbahrani AR, Haghi N, Khanlarzadeh E. Comparison of Tranexamic Acid and Dexmedetomidine on Bleeding in Endoscopic Sinus Surgery. Iran J Otorhinolaryngol. 2023 Jan;35(126):49-56. doi: 10.22038/IJORL.2022.64361.3203.'}, {'pmid': '34213494', 'type': 'BACKGROUND', 'citation': 'Modir H, Moshiri E, Naseri N, Faraji F, Almasi-Hashiani A. A randomized parallel design trial of the efficacy and safety of tranexamic acid, dexmedetomidine and nitroglycerin in controlling intraoperative bleeding and improving surgical field quality during septorhinoplasty under general anesthesia. Med Gas Res. 2021 Oct-Dec;11(4):131-137. doi: 10.4103/2045-9912.318857.'}]}, 'descriptionModule': {'briefSummary': 'The most common procedure said to involve substantial bleeding is spine surgery. There is always a significant danger of bleeding and blood transfusion associated with these procedures, particularly complex and multilevel spine surgeries. Care of bleeding should be taken, as excessive blood loss can lead to impaired vision of surgical field, anemia, postoperative epidural hematoma and transfusion-related complications as transfusion reactions and transmission of infections.\n\nFor these reasons, improving surgical field is a must. Hemostasis procedures, including good positioning, controlled hypotension, local vasoconstrictors, epidural block, biological and chemical medications including desmopressin, aprotinin, tranexamic acid, epsilon, aminocaproic acid, dexmedetomidine, can all be used to decrease bleeding.\n\nand In this study we compared the effect of tranexamic acid and dexmedetomidine on hemodynamics, blood loss, transfusion and the quality of the surgical field.\n\nSample size was 78 cases who underwent lumbar decompression and fixation surgery at 2 levels. They were divided into 3 equal groups (26 patients in each one) :\n\n1. Control grup (group C): received loading IV infusion of 50 ml saline over 10 min before induction of anesthesia, then maintenance IV infusion of saline.\n2. Tranexamic acid group (group T): received loading dose of tranexamic acid 10 mg/kg over 10 min before induction of\n\n anesthesia, then maintenance IV infusion of tranexamic acid 1mg/kg/h.\n3. Dexmedetomidine group (group D): received loading dose of dexmedetomidine 1 μg/kg over 10 min before induction of anesthesia, then maintenance IV infusion of dexmedetomidine 0.3-0.7 μg/kg/h.\n\nWe compared the 3 groups regarding these characteristics : - Age, sex, body mass index and ASA classification\n\n* Hemodynamics (mean arterial pressure \\& heart rate) and oxygen saturation.\n* Amount of blood loss, blood transfusion, pre and post operative hemoglobin and hematocrit levels.\n* Side effects, duration of surgery, emergence and discharge times.\n* Score of intraoperative surgical field. The results revealed that dexmedetomidine achieved more hypotensive and bradycardiac effects than other study drugs, but tranexamic acid had the upper hand in decreasing the amount of blood loss and blood transfusion. Side effects were more in dexmedetomidine group than other groups, represented mainly as hypotension and bradycardia. Duration of surgery was shorter in tranexamic acid group than other groups. Emergence and discharge times were longer in dexmedetomidine group than other groups. There was no statistical significant difference between the 3 groups in surgical field score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient consent. 2. Age: 21-60 years old. 3. Physical status: ASA І \\& II. 4. BMI: 18.5-30 kg/m2. 5. Type of operations : elective lumbar decompression and fixation surgeries at 2 levels. 6. Time of operation : less than 4 hours. 7. Type of anesthesia : general anesthesia.\n\nExclusion Criteria:\n\n* 1\\. known history of allergy to study drugs. 2. Central nervous system disorder and metabolic diseases. 3. History or risk of thrombosis or active thromboembolic disease as deep vein thrombosis and pulmonary embolism. 4. Coagulopathies or taking drugs affecting coagulation ( INR\\>1.5 , PLatelets count less than 100.000 per microliter of blood ). 5. Patients on B- blockers.'}, 'identificationModule': {'nctId': 'NCT06587620', 'briefTitle': 'Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Tranexamic Acid Versus Dexmedetomidine for Improving Surgical Field Quality During Spine Surgeries', 'orgStudyIdInfo': {'id': '11228-8/10-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control group (group c ) : saline', 'description': 'IV infusion of 50 ml saline over 10 min before induction of anesthesia. IV saline infusion immediately after induction till 15 min before the end of surgery.', 'interventionNames': ['Other: Saline (NaCl 0,9 %) (placebo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid group (group T)', 'description': 'Start IV infusion of a loading dose of tranexamic acid 10 mg/kg completed to 50 ml saline over 10 min before induction of anesthesia. IV infusion of tranexamic acid at a dose of 1 mg/kg/h immediately after induction till 15 min before the end of surgery.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine group (group D).', 'description': 'Start IV infusion of a loading dose of dexmedetomidine 1ug/kg completed to 50 ml saline over 10 min before induction of anesthesia. IV infusion of dexmedetomidine 0.3-0.7 µg/kg/h immediately after induction to maintain Mean Arterial Pressure (MAP) between 60-70 mmHg till 15 min before the end of surgery.', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'description': 'Start IV infusion of a loading dose of tranexamic acid 10 mg/kg completed to 50 ml saline over 10 min before induction of anesthesia. IV infusion of tranexamic acid at a dose of 1 mg/kg/h immediately after induction till 15 min before the end of surgery.', 'armGroupLabels': ['Tranexamic acid group (group T)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Start IV infusion of a loading dose of dexmedetomidine 1ug/kg completed to 50 ml saline over 10 min before induction of anesthesia. IV infusion of dexmedetomidine 0.3-0.7 µg/kg/h immediately after induction to maintain Mean Arterial Pressure (MAP) between 60-70 mmHg till 15 min before the end of surgery.', 'armGroupLabels': ['Dexmedetomidine group (group D).']}, {'name': 'Saline (NaCl 0,9 %) (placebo)', 'type': 'OTHER', 'description': 'IV infusion of 50 ml saline over 10 min before induction of anesthesia. IV saline infusion immediately after induction till 15 min before the end of surgery.', 'armGroupLabels': ['control group (group c ) : saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Elsharqya', 'country': 'Egypt', 'facility': 'Faculty of medicine, zagazig university', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}, {'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and surgical intensive care', 'investigatorFullName': 'manal mohamed rashad', 'investigatorAffiliation': 'Zagazig University'}}}}