Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT06289335
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2024-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Period of time', 'timeFrame': 'one hour', 'description': 'period of time in which post-anesthetic tremor is controlled from the moment of administration'}], 'secondaryOutcomes': [{'measure': 'Adverse effects', 'timeFrame': 'one hour', 'description': 'To measure the frequencies of occurrence of adverse effects and changes in vital signs (heart rate, blood pressure, and temperature \\[measured at the tympanic membrane\\]) correlated with resolution of tremor.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shivering, dexmedetomidine, ondansetron, regional anesthesia'], 'conditions': ['Postanesthetic Excitement', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '29756066', 'type': 'BACKGROUND', 'citation': 'Lopez MB. Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care. 2018 Apr;25(1):73-81. doi: 10.21454/rjaic.7518.251.xum.'}, {'pmid': '29278601', 'type': 'BACKGROUND', 'citation': 'Jain A, Gray M, Slisz S, Haymore J, Badjatia N, Kulstad E. Shivering Treatments for Targeted Temperature Management: A Review. J Neurosci Nurs. 2018 Apr;50(2):63-67. doi: 10.1097/JNN.0000000000000340.'}, {'pmid': '11682416', 'type': 'BACKGROUND', 'citation': 'Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.'}, {'pmid': '9357885', 'type': 'BACKGROUND', 'citation': 'Talke P, Tayefeh F, Sessler DI, Jeffrey R, Noursalehi M, Richardson C. Dexmedetomidine does not alter the sweating threshold, but comparably and linearly decreases the vasoconstriction and shivering thresholds. Anesthesiology. 1997 Oct;87(4):835-41. doi: 10.1097/00000542-199710000-00017.'}, {'pmid': '18205960', 'type': 'BACKGROUND', 'citation': 'Elvan EG, Oc B, Uzun S, Karabulut E, Coskun F, Aypar U. Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. Eur J Anaesthesiol. 2008 May;25(5):357-64. doi: 10.1017/S0265021507003110. Epub 2008 Jan 21.'}, {'pmid': '26767820', 'type': 'RESULT', 'citation': 'Hoffman J, Hamner C. Effectiveness of dexmedetomidine use in general anesthesia to prevent postoperative shivering: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan 15;13(12):287-313. doi: 10.11124/jbisrir-2015-2257.'}, {'pmid': '30643009', 'type': 'RESULT', 'citation': 'Yu G, Jin S, Chen J, Yao W, Song X. The effects of novel alpha2-adrenoreceptor agonist dexmedetomidine on shivering in patients underwent caesarean section. Biosci Rep. 2019 Feb 1;39(2):BSR20181847. doi: 10.1042/BSR20181847. Print 2019 Feb 28.'}, {'pmid': '27228512', 'type': 'RESULT', 'citation': 'Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.'}, {'pmid': '27138855', 'type': 'RESULT', 'citation': 'He K, Zhao H, Zhou HC. Efficiency and safety of ondansetron in preventing postanaesthesia shivering. Ann R Coll Surg Engl. 2016 Jul;98(6):358-66. doi: 10.1308/rcsann.2016.0152. Epub 2016 May 3.'}, {'pmid': '28663651', 'type': 'RESULT', 'citation': 'Nallam SR, Cherukuru K, Sateesh G. Efficacy of Intravenous Ondansetron for Prevention of Postspinal Shivering during Lower Segment Cesarean Section: A Double-Blinded Randomized Trial. Anesth Essays Res. 2017 Apr-Jun;11(2):508-513. doi: 10.4103/aer.AER_26_17.'}, {'pmid': '30501612', 'type': 'RESULT', 'citation': 'Botros JM, Mahmoud AMS, Ragab SG, Ahmed MAA, Roushdy HMS, Yassin HM, Bolus ML, Goda AS. Comparative study between Dexmedetomidine and Ondansteron for prevention of post spinal shivering. A randomized controlled trial. BMC Anesthesiol. 2018 Nov 30;18(1):179. doi: 10.1186/s12871-018-0640-3.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.', 'detailedDescription': 'Randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with ASA (American Society of Anesthesiologist) II or III, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the BSAS (Bedside shivering assessment scale) scale, at the Hospital Central from San Luis Potosi, Mexico. The main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; The evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA II or III, undergoing scheduled or emergency cesarean section with regional anesthesia (hyperbaric bupivacaine 0.5% with morphine at 1 mcg Kg-1) and who presented tremor grade \\>1 based on the BSAS scale\n\nExclusion Criteria:\n\n* Hemodynamic instability, heart disease or sinus bradycardia, allergy to any of the medications applied, psychiatric diseases or hypothermia \\<35.2 ºC measured by tympanic temperature.'}, 'identificationModule': {'nctId': 'NCT06289335', 'briefTitle': 'Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Central "Dr. Ignacio Morones Prieto"'}, 'officialTitle': 'Dexmedetomidine Compared With Ondansetron in Treating Postanesthetic Shivering in Patients After Regional Anesthesia for Cesarean Section-a Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'HCDrIMPrieto anaesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': '0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline', 'interventionNames': ['Drug: saline solution']}, {'type': 'SHAM_COMPARATOR', 'label': 'Ondansetron', 'description': '8 mg ondansetron IV in 20 mL saline', 'interventionNames': ['Drug: saline solution']}], 'interventions': [{'name': 'saline solution', 'type': 'DRUG', 'otherNames': ['isotonic solution'], 'description': '20 mL of saline', 'armGroupLabels': ['Dexmedetomidine', 'Ondansetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78290', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Hospital Central Dr. Ignacio Morones Prieto', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}], 'overallOfficials': [{'name': 'MARIO A MARTÍNEZ-JIMÉNEZ, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Central "Dr. Ignacio Morones Prieto"'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It might be useful for other researchers to expand their investigations, nevertheless, in this moment it seems completed this branch of investigation.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Central "Dr. Ignacio Morones Prieto"', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'MARIO AURELIO MARTÍNEZ-JIMÉNEZ', 'investigatorAffiliation': 'Hospital Central "Dr. Ignacio Morones Prieto"'}}}}