Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-01 @ 8:15 PM
Study NCT ID:
NCT05063292
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prewarming On Skin Temperature Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007035', 'term': 'Hypothermia'}], 'ancestors': [{'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study covers 2 groups. Group I will be covered with warmed double layered cotton cloth. Group II will be covered with air forced blanket.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-11-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peripheral skin temperature at ( F0)', 'timeFrame': 'just after spinal anesthesia done', 'description': 'F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature at( S0)', 'timeFrame': 'just after spinal anesthesia done', 'description': 'S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature( T0)', 'timeFrame': 'just after spinal anesthesia done', 'description': 'T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( M0)', 'timeFrame': 'just after spinal anesthesia done', 'description': 'M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( F1)', 'timeFrame': '60 seconds after spinal anesthesia done', 'description': 'F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F2)', 'timeFrame': '120 seconds after spinal anesthesia done', 'description': 'F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F3)', 'timeFrame': '180 seconds after spinal anesthesia done', 'description': 'F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F4)', 'timeFrame': '4 minute after spinal anesthesia done', 'description': 'F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F5)', 'timeFrame': '5 minute after spinal anesthesia done', 'description': 'F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F6)', 'timeFrame': '6 minute after spinal anesthesia done', 'description': 'F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F7)', 'timeFrame': '7 minute after spinal anesthesia done', 'description': 'F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F8)', 'timeFrame': '8 minute after spinal anesthesia done', 'description': 'F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F9)', 'timeFrame': '9 minute after spinal anesthesia done', 'description': 'F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F10)', 'timeFrame': '10 minute after spinal anesthesia done', 'description': 'F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F15)', 'timeFrame': '15 minute after spinal anesthesia done', 'description': 'F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F20)', 'timeFrame': '20 minute after spinal anesthesia done', 'description': 'F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F25)', 'timeFrame': '25 minute after spinal anesthesia done', 'description': 'F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F30)', 'timeFrame': '30 minute after spinal anesthesia done', 'description': 'F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F35)', 'timeFrame': '35 minute after spinal anesthesia done', 'description': 'F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F40)', 'timeFrame': '40 minute after spinal anesthesia done', 'description': 'F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F45)', 'timeFrame': '45 minute after spinal anesthesia done', 'description': 'F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F50)', 'timeFrame': '50 minute after spinal anesthesia done', 'description': 'F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F55)', 'timeFrame': '55 minute after spinal anesthesia done', 'description': 'F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature( F60)', 'timeFrame': '60 minute after spinal anesthesia done', 'description': 'F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe'}, {'measure': 'peripheral skin temperature at( S1)', 'timeFrame': '60 seconds after spinal anesthesia done', 'description': 'S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S2)', 'timeFrame': '120 seconds after spinal anesthesia done', 'description': 'S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S3)', 'timeFrame': '180 seconds after spinal anesthesia done', 'description': 'S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S4)', 'timeFrame': '4 minute after spinal anesthesia done', 'description': 'S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S5)', 'timeFrame': '5 minute after spinal anesthesia done', 'description': 'S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S6)', 'timeFrame': '6 minute after spinal anesthesia done', 'description': 'S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S7)', 'timeFrame': '7 minute after spinal anesthesia done', 'description': 'S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S8)', 'timeFrame': '8 minute after spinal anesthesia done', 'description': 'S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S9)', 'timeFrame': '9 minute after spinal anesthesia done', 'description': 'S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S10)', 'timeFrame': '10 minute after spinal anesthesia done', 'description': 'S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S15)', 'timeFrame': '15 minute after spinal anesthesia done', 'description': 'S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S20)', 'timeFrame': '20 minute after spinal anesthesia done', 'description': 'S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S25)', 'timeFrame': '25 minute after spinal anesthesia done', 'description': 'S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S30)', 'timeFrame': '30 minute after spinal anesthesia done', 'description': 'S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S35)', 'timeFrame': '35 minute after spinal anesthesia done', 'description': 'S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S40)', 'timeFrame': '40 minute after spinal anesthesia done', 'description': 'S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S45)', 'timeFrame': '45 minute after spinal anesthesia done', 'description': 'S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S50)', 'timeFrame': '50 minute after spinal anesthesia done', 'description': 'S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S55)', 'timeFrame': '55 minute after spinal anesthesia done', 'description': 'S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature at( S60)', 'timeFrame': '60 minute after spinal anesthesia done', 'description': 'S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe'}, {'measure': 'peripheral skin temperature( T1)', 'timeFrame': '60 seconds after spinal anesthesia done', 'description': 'T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T2)', 'timeFrame': '120 seconds after spinal anesthesia done', 'description': 'T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T3)', 'timeFrame': '180 seconds after spinal anesthesia done', 'description': 'T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T4)', 'timeFrame': '4 minute after spinal anesthesia done', 'description': 'T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T5)', 'timeFrame': '5 minute after spinal anesthesia done', 'description': 'T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T6)', 'timeFrame': '6 minute after spinal anesthesia done', 'description': 'T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T7)', 'timeFrame': '7 minute after spinal anesthesia done', 'description': 'T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T8)', 'timeFrame': '8 minute after spinal anesthesia done', 'description': 'T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T9)', 'timeFrame': '9 minute after spinal anesthesia done', 'description': 'T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T10)', 'timeFrame': '10 minute after spinal anesthesia done', 'description': 'T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T15)', 'timeFrame': '15 minute after spinal anesthesia done', 'description': 'T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T20)', 'timeFrame': '20 minute after spinal anesthesia done', 'description': 'T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T25)', 'timeFrame': '25 minute after spinal anesthesia done', 'description': 'T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T30)', 'timeFrame': '30 minute after spinal anesthesia done', 'description': 'T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T35)', 'timeFrame': '35 minute after spinal anesthesia done', 'description': 'T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T40)', 'timeFrame': '40 minute after spinal anesthesia done', 'description': 'T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T45)', 'timeFrame': '45 minute after spinal anesthesia done', 'description': 'T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T50)', 'timeFrame': '50 minute after spinal anesthesia done', 'description': 'T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T55)', 'timeFrame': '55 minute after spinal anesthesia done', 'description': 'T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( T60)', 'timeFrame': '60 minute after spinal anesthesia done', 'description': 'T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe'}, {'measure': 'peripheral skin temperature( M1)', 'timeFrame': '60 seconds after spinal anesthesia done', 'description': 'M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M2)', 'timeFrame': '120 seconds after spinal anesthesia done', 'description': 'M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M3)', 'timeFrame': '180 seconds after spinal anesthesia done', 'description': 'M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M4)', 'timeFrame': '4 minute after spinal anesthesia done', 'description': 'M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M5)', 'timeFrame': '5 minute after spinal anesthesia done', 'description': 'M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M6)', 'timeFrame': '6 minute after spinal anesthesia done', 'description': 'M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M7)', 'timeFrame': '7 minute after spinal anesthesia done', 'description': 'M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M8)', 'timeFrame': '8 minute after spinal anesthesia done', 'description': 'M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M9)', 'timeFrame': '9 minute after spinal anesthesia done', 'description': 'M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M10)', 'timeFrame': '10 minute after spinal anesthesia done', 'description': 'M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M15)', 'timeFrame': '15 minute after spinal anesthesia done', 'description': 'M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M20)', 'timeFrame': '20 minute after spinal anesthesia done', 'description': 'M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M25)', 'timeFrame': '25 minute after spinal anesthesia done', 'description': 'M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M30)', 'timeFrame': '30 minute after spinal anesthesia done', 'description': 'M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M35)', 'timeFrame': '35 minute after spinal anesthesia done', 'description': 'M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M40)', 'timeFrame': '40 minute after spinal anesthesia done', 'description': 'M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M45)', 'timeFrame': '45 minute after spinal anesthesia done', 'description': 'M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M50)', 'timeFrame': '50 minute after spinal anesthesia done', 'description': 'M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M55)', 'timeFrame': '55 minute after spinal anesthesia done', 'description': 'M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}, {'measure': 'peripheral skin temperature( M60)', 'timeFrame': '60 minute after spinal anesthesia done', 'description': 'M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe'}], 'secondaryOutcomes': [{'measure': 'core tympanic membrane temperature (C0)', 'timeFrame': 'just before spinal anesthesia done', 'description': 'centigrade degree , Timpanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,'}, {'measure': 'core tympanic membrane temperature(C1)', 'timeFrame': '15 minute after spinal anesthesia done', 'description': 'centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,'}, {'measure': 'core tympanic membrane temperature(C2)', 'timeFrame': '30 minute after spinal anesthesia done', 'description': 'centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,'}, {'measure': 'core tympanic membrane temperature(C3)', 'timeFrame': '45 minute after spinal anesthesia done', 'description': 'centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,'}, {'measure': 'core tympanic membrane temperature(C4)', 'timeFrame': '60 minute after spinal anesthesia done', 'description': 'centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504,'}, {'measure': 'thermal comfort scale', 'timeFrame': 'Immediately after the surgery', 'description': 'thermal comfort will be rated on a 100mm visual analog scale (VAS),with zero indicating intense cold and 100mm representing intense heat'}, {'measure': 'shivering score(h0)', 'timeFrame': 'just before spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h1)', 'timeFrame': '15 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h2)', 'timeFrame': '30 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h3)', 'timeFrame': '45 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h4)', 'timeFrame': '60 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h5)', 'timeFrame': '75 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h6)', 'timeFrame': '90 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h7)', 'timeFrame': '105 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}, {'measure': 'shivering score(h8)', 'timeFrame': '120 minute after spinal anesthesia done', 'description': '0: no shivering 1:piloerection or peripheral vasoconstriction but no visible shivering 2: muscular activity in only one muscle group 3:muscular activity in more then one muscle group but not generalized shivering 4:shivering involving the whole body'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypothermia', 'peripheral temperature', 'spinal anesthesia', 'forced-air warming'], 'conditions': ['Spinal Anesthesia', 'Hypothermia Following Anesthesia', 'Prewarming', 'Core Temperature', 'Urological Cancer']}, 'referencesModule': {'references': [{'pmid': '29938773', 'type': 'BACKGROUND', 'citation': 'Hermanns H, Werdehausen R, Hollmann MW, Stevens MF. Assessment of skin temperature during regional anaesthesia-What the anaesthesiologist should know. Acta Anaesthesiol Scand. 2018 Oct;62(9):1280-1289. doi: 10.1111/aas.13176. Epub 2018 Jun 25.'}, {'pmid': '30579334', 'type': 'BACKGROUND', 'citation': 'Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.'}, {'pmid': '19996770', 'type': 'BACKGROUND', 'citation': 'Fradkin AJ, Zazryn TR, Smoliga JM. Effects of warming-up on physical performance: a systematic review with meta-analysis. J Strength Cond Res. 2010 Jan;24(1):140-8. doi: 10.1519/JSC.0b013e3181c643a0.'}, {'pmid': '11137413', 'type': 'BACKGROUND', 'citation': 'Frank SM, El-Rahmany HK, Tran KM, Vu B, Raja SN. Comparison of lower extremity cutaneous temperature changes in patients receiving lumbar sympathetic ganglion blocks versus epidural anesthesia. J Clin Anesth. 2000 Nov;12(7):525-30. doi: 10.1016/s0952-8180(00)00207-5.'}, {'pmid': '26571323', 'type': 'BACKGROUND', 'citation': 'Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70.'}, {'pmid': '38206216', 'type': 'DERIVED', 'citation': 'Nayebi N, Tekgul ZT, Sahinkaya HH. Effect of Prewarming on Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of the Bladder. J Perianesth Nurs. 2024 Jun;39(3):391-396. doi: 10.1016/j.jopan.2023.08.020. Epub 2024 Jan 11.'}]}, 'descriptionModule': {'briefSummary': 'In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.', 'detailedDescription': "In this prospective single-blind study, patients will be divided into 2 groups with computer-based randomization technique. All patients will have a fasting time of 2 hours for clear fluid and 6 hours for solid food. Patients will be taken to the premedication room before the operation. Written and verbal approval will be taken from all patients. Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer,every 15 minutes.Adult skin temperature probe will be used for continuous peripheral temperature measurement from four different body areas (T1:Cervical7 (C7) dermatome, T2:C6 dermatome T3:Lumbar 5( L5 )dermatome, T4: L4 dermatome). The two groups will have an infusion of balanced electrolyte solution with a rate of 8 Mililitre/Kilogram/ hour(mL/kg/hour). Patients in Group I will be covered with a 41 centigrade degrees double layered cotton clothes. Patients in Group II will receive active prewarming with a forced-air warming blanket (WarmCare full body blanket) 30 minutes prior to the operation. 0.1 mg/kg intravenous (iv) midazolam hydrochloride will be administered for premedication. Patients will be transferred to operating room, covered with warmed double layered cotton clothes. Standard monitoring (pulse oximetry, noninvasive blood pressure, electrocardiography) will be applied to the patients. Core temperature and 4-points skin temperature measurements will be recorded. Patients will be delivered 2 Liter/minute oxygen with a nasal cannula. Iv hydration will be continued by room temperature balanced electrolyte solution with an infusion rate of 2mililiter/kilogram/hour. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position. Then patients will be taken supine position. Hemodynamic measurements will be continued. Core temperature measurements will be done every 15 minutes. Peripheral skin temperature measurements will be continuous. 1st, 2nd ,3rd,4th ,5th ,6th, 7th, 8th, 9th and 10th minutes and every 5 minutes measurements will be recorded during the operation. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. The time for adequate sensorial block (T10) will be recorded. The patients will be repositioned (lithotomy) before the beginning of surgery. 5 mg iv ephedrine and 0.5 mg iv atropine will be administered when the blood pressure will be %80 of the baseline pressure and heart rate. Operating time, amount and temperature of irrigation fluids, transfusion requirement will be recorded. All patients will be transferred to post anesthesia care unit (PACU). Core temperature measurements will be continued every 15 minutes at PACU. Shivering scale and thermal comfort scale will be used during and after the operation. 25 mg iv meperidine will be administered when the patient's shivering score will be more than 3. Length of PACU stay will be recorded."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'Male patients scheduled for transurethral bladder resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II-III\n* 50-80 years old\n* Patients scheduled for transurethral baldder resection\n\nExclusion Criteria:\n\n* Female gender\n* Uncoordinated patients\n* Have coagulopathy,\n* Known allergies to drugs to be used,\n* Patients diagnosed with severe hypovolemia\n* Skin infection at the injection site.\n* Body mass index greater than 35m2/kg\n* patients with severe endocrinological disease\n* Patients with cardiovascular diseases\n* patients with severe aortic stenosis or severe mitral stenosis\n* patients with increased intracranial pressure'}, 'identificationModule': {'nctId': 'NCT05063292', 'briefTitle': 'Effect of Prewarming On Skin Temperature Changes', 'organization': {'class': 'OTHER', 'fullName': 'Bozyaka Training and Research Hospital'}, 'officialTitle': 'Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder', 'orgStudyIdInfo': {'id': 'NeginIzmirBozyaka'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients covered with a 41 centigrade degrees double layered cotton cloth'}, {'type': 'EXPERIMENTAL', 'label': 'Prewarmed group', 'description': 'Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation', 'interventionNames': ['Procedure: Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation']}], 'interventions': [{'name': 'Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation', 'type': 'PROCEDURE', 'description': 'Core temperature and 4-points skin temperatures measurements will be recorded all over the operation. Patients will be delivered 2 Litre/minute oxygen with a nasal cannula.Iv hydration will be continued by room temperatured balanced electrolyte solution with an infusion rate of 2mL/kg/hr. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position.', 'armGroupLabels': ['Prewarmed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35170', 'city': 'Izmir', 'state': 'Karabağlar', 'country': 'Turkey (Türkiye)', 'facility': 'Bozyaka Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Negin Nayebi, MD', 'role': 'CONTACT', 'email': 'negin.naebi@gmail.com', 'phone': '+905541491707'}, {'name': 'Zeki Tuncel Tekgül, Assoc Prof', 'role': 'CONTACT', 'email': 'zekitekgul@yahoo.com', 'phone': '+905058554705'}], 'overallOfficials': [{'name': 'Halide Hande Şahinkaya, Specialist', 'role': 'STUDY_CHAIR', 'affiliation': 'Izmir Bozyaka Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozyaka Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Anesthesiology Resident', 'investigatorFullName': 'NEGIN NAYEBI', 'investigatorAffiliation': 'Bozyaka Training and Research Hospital'}}}}