Spinal Anesthesia Clinical Trial
Official title:
Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | November 18, 2021 |
Est. primary completion date | November 10, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - ASA I-II-III - 50-80 years old - Patients scheduled for transurethral baldder resection Exclusion Criteria: - Female gender - Uncoordinated patients - Have coagulopathy, - Known allergies to drugs to be used, - Patients diagnosed with severe hypovolemia - Skin infection at the injection site. - Body mass index greater than 35m2/kg - patients with severe endocrinological disease - Patients with cardiovascular diseases - patients with severe aortic stenosis or severe mitral stenosis - patients with increased intracranial pressure |
Country | Name | City | State |
---|---|---|---|
Turkey | Bozyaka Training and Research Hospital | Izmir | Karabaglar |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | peripheral skin temperature at ( F0) | F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | just after spinal anesthesia done | |
Primary | peripheral skin temperature at( S0) | S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | just after spinal anesthesia done | |
Primary | peripheral skin temperature( T0) | T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | just after spinal anesthesia done | |
Primary | peripheral skin temperature( M0) | M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | just after spinal anesthesia done | |
Primary | peripheral skin temperature( F1) | F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 60 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( F2) | F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 120 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( F3) | F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 180 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( F4) | F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 4 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F5) | F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 5 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F6) | F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 6 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F7) | F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 7 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F8) | F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 8 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F9) | F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 9 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F10) | F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 10 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F15) | F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 15 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F20) | F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 20 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F25) | F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 25 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F30) | F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 30 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F35) | F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 35 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F40) | F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 40 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F45) | F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 45 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F50) | F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 50 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F55) | F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 55 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( F60) | F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe | 60 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S1) | S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 60 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature at( S2) | S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 120 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature at( S3) | S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 180 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature at( S4) | S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 4 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S5) | S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 5 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S6) | S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 6 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S7) | S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 7 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S8) | S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 8 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S9) | S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 9 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S10) | S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 10 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S15) | S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 15 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S20) | S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 20 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S25) | S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 25 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S30) | S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 30 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S35) | S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 35 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S40) | S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 40 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S45) | S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 45 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S50) | S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 50 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S55) | S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 55 minute after spinal anesthesia done | |
Primary | peripheral skin temperature at( S60) | S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe | 60 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T1) | T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 60 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( T2) | T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 120 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( T3) | T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 180 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( T4) | T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 4 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T5) | T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 5 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T6) | T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 6 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T7) | T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe | 7 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T8) | T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 8 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T9) | T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 9 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T10) | T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 10 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T15) | T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 15 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T20) | T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 20 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T25) | T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe | 25 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T30) | T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 30 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T35) | T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 35 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T40) | T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 40 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T45) | T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 45 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T50) | T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 50 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T55) | T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 55 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( T60) | T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe | 60 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M1) | M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 60 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( M2) | M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 120 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( M3) | M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 180 seconds after spinal anesthesia done | |
Primary | peripheral skin temperature( M4) | M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 4 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M5) | M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 5 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M6) | M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 6 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M7) | M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 7 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M8) | M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 8 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M9) | M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 9 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M10) | M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 10 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M15) | M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 15 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M20) | M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 20 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M25) | M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 25 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M30) | M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 30 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M35) | M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 35 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M40) | M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 40 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M45) | M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 45 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M50) | M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 50 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M55) | M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 55 minute after spinal anesthesia done | |
Primary | peripheral skin temperature( M60) | M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe | 60 minute after spinal anesthesia done | |
Secondary | core tympanic membrane temperature (C0) | centigrade degree , Timpanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504, | just before spinal anesthesia done | |
Secondary | core tympanic membrane temperature(C1) | centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504, | 15 minute after spinal anesthesia done | |
Secondary | core tympanic membrane temperature(C2) | centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504, | 30 minute after spinal anesthesia done | |
Secondary | core tympanic membrane temperature(C3) | centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504, | 45 minute after spinal anesthesia done | |
Secondary | core tympanic membrane temperature(C4) | centigrade degree , Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer, CTD504, | 60 minute after spinal anesthesia done | |
Secondary | thermal comfort scale | thermal comfort will be rated on a 100mm visual analog scale (VAS),with zero indicating intense cold and 100mm representing intense heat | Immediately after the surgery | |
Secondary | shivering score(h0) | 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 | just before spinal anesthesia done | |
Secondary | shivering score(h1) | 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 | 15 minute after spinal anesthesia done | |
Secondary | shivering score(h2) | 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 | 30 minute after spinal anesthesia done | |
Secondary | shivering score(h3) | 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 | 45 minute after spinal anesthesia done | |
Secondary | shivering score(h4) | 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 | 60 minute after spinal anesthesia done | |
Secondary | shivering score(h5) | 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 | 75 minute after spinal anesthesia done | |
Secondary | shivering score(h6) | 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 | 90 minute after spinal anesthesia done | |
Secondary | shivering score(h7) | 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 | 105 minute after spinal anesthesia done | |
Secondary | shivering score(h8) | 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 | 120 minute after spinal anesthesia done |
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