Effect of Prewarming On Skin Temperature Changes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder

Conditions
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Spinal Anesthesia, Hypothermia Following Anesthesia, Prewarming, Core Temperature, Urological Cancer

Intervention / Treatment
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* Procedure: Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Patients covered with a 41 centigrade degrees double layered cotton cloth | |
| Experimental: Prewarmed group<br>Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation | Procedure: Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypothermia, peripheral temperature, spinal anesthesia, forced-air warming