Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-30 @ 6:38 PM
Study NCT ID:
NCT04133961
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2019-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-05', 'studyFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2019-10-17', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence and intensity of shivering', 'timeFrame': '2 hours', 'description': 'Any presence of shivering intraoperatively is recorded. The intensity of shivering is recorded based on the Bedside Shivering Assessment Scale (BSAS) with a scoring of 0-3 (0 = no shivering, 1 = shivering localised to neck and/or thorax, 2 = shivering involves gross movement of upper extremities, 3 = shivering involves gross movements of the trunk, upper and lower extremities).'}], 'secondaryOutcomes': [{'measure': "Change in patient's core and skin temperature", 'timeFrame': '2 hours', 'description': "Patient's core (tympanic membrane) and skin (forehead) temperature is measured using an infrared thermometer."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phenylephrine', 'Spinal anaesthesia'], 'conditions': ['Postoperative Shivering']}, 'referencesModule': {'references': [{'pmid': '10439767', 'type': 'BACKGROUND', 'citation': 'Ikeda T, Ozaki M, Sessler DI, Kazama T, Ikeda K, Sato S. Intraoperative phenylephrine infusion decreases the magnitude of redistribution hypothermia. Anesth Analg. 1999 Aug;89(2):462-5. doi: 10.1097/00000539-199908000-00040.'}, {'pmid': '20146867', 'type': 'BACKGROUND', 'citation': 'Ro Y, Huh J, Min S, Han S, Hwang J, Yang S, Kim DK, Kim C. Phenylephrine attenuates intra-operative hypothermia during spinal anaesthesia. J Int Med Res. 2009 Nov-Dec;37(6):1701-8. doi: 10.1177/147323000903700605.'}, {'pmid': '32500108', 'type': 'BACKGROUND', 'citation': 'Hilton EJ, Wilson SH, Wolf BJ, Hand W, Roberts L, Hebbar L. Effect of Intraoperative Phenylephrine Infusion on Redistribution Hypothermia During Cesarean Delivery Under Spinal Anesthesia. J Clin Anesth Manag. 2016 Jan;1(1):10.16966/2470-9956.103. doi: 10.16966/2470-9956.103. Epub 2015 Dec 19.'}, {'pmid': '18927450', 'type': 'BACKGROUND', 'citation': 'Badjatia N, Strongilis E, Gordon E, Prescutti M, Fernandez L, Fernandez A, Buitrago M, Schmidt JM, Ostapkovich ND, Mayer SA. Metabolic impact of shivering during therapeutic temperature modulation: the Bedside Shivering Assessment Scale. Stroke. 2008 Dec;39(12):3242-7. doi: 10.1161/STROKEAHA.108.523654. Epub 2008 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'Assessment of whether and how phenylephrine infusion reduces postoperative shivering in spinal anaesthesia.', 'detailedDescription': 'This study aims to evaluate whether phenylephrine infusion can reduce postoperative shivering among patients scheduled for elective lower segment caesarean section under spinal anaesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients who are planned for elective lower segment caesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 18 years of age\n* American Society of Anesthesiologists (ASA) II patients\n* Patients with singleton pregnancy who are scheduled to undergo elective lower segment caesarean section under spinal anaesthesia\n\nExclusion Criteria:\n\n* Patients with contraindication to phenylephrine\n* Patients with evidence of fever or infection, or hypothermia preoperatively\n* BMI ≥ 40\n* Height \\<150cm'}, 'identificationModule': {'nctId': 'NCT04133961', 'briefTitle': 'Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Kebangsaan Malaysia Medical Centre'}, 'officialTitle': 'Intraoperative Phenylephrine Infusion to Reduce Postoperative Shivering in Lower Segment Caesarean Section', 'orgStudyIdInfo': {'id': 'FF-2019-273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Phenylephrine)', 'description': 'Phenylephrine infusion started immediately after administration of spinal block', 'interventionNames': ['Drug: Phenylephrine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group B (Saline)', 'description': 'Normal saline infusion started immediately after administration of spinal block', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Phenylephrine', 'type': 'DRUG', 'description': 'Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)', 'armGroupLabels': ['Group A (Phenylephrine)']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)', 'armGroupLabels': ['Group B (Saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Pusat Perubatan Universiti Kebangsaan Malaysia', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Syarifah Noor Nazihah Sayed Masri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anaesthesiologist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Kebangsaan Malaysia Medical Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}