Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- peripheral skin temperature( F9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA I-II-III
- •50-80 years old
- •Patients scheduled for transurethral baldder resection
排除标准
- •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
研究组 & 干预措施
Control group
Patients covered with a 41 centigrade degrees double layered cotton cloth
Prewarmed group
Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation
干预措施: Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation (Procedure)
结局指标
主要结局
peripheral skin temperature( F9)
时间窗: 9 minute after spinal anesthesia done
F9 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F15)
时间窗: 15 minute after spinal anesthesia done
F15 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S45)
时间窗: 45 minute after spinal anesthesia done
S45 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S60)
时间窗: 60 minute after spinal anesthesia done
S60 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T2)
时间窗: 120 seconds after spinal anesthesia done
T2 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T4)
时间窗: 4 minute after spinal anesthesia done
T4 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( F45)
时间窗: 45 minute after spinal anesthesia done
F45 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( T0)
时间窗: just after spinal anesthesia done
T0 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M0)
时间窗: just after spinal anesthesia done
M0 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( F1)
时间窗: 60 seconds after spinal anesthesia done
F1will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F20)
时间窗: 20 minute after spinal anesthesia done
F20 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S4)
时间窗: 4 minute after spinal anesthesia done
S4 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S20)
时间窗: 20 minute after spinal anesthesia done
S20 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S50)
时间窗: 50 minute after spinal anesthesia done
S50 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S55)
时间窗: 55 minute after spinal anesthesia done
S55 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T1)
时间窗: 60 seconds after spinal anesthesia done
T1 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T8)
时间窗: 8 minute after spinal anesthesia done
T8 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( F5)
时间窗: 5 minute after spinal anesthesia done
F5 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F8)
时间窗: 8 minute after spinal anesthesia done
F8 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F25)
时间窗: 25 minute after spinal anesthesia done
F25 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S1)
时间窗: 60 seconds after spinal anesthesia done
S1 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( F3)
时间窗: 180 seconds after spinal anesthesia done
F3 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F4)
时间窗: 4 minute after spinal anesthesia done
F4 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F6)
时间窗: 6 minute after spinal anesthesia done
F6 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F7)
时间窗: 7 minute after spinal anesthesia done
F7 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S0)
时间窗: just after spinal anesthesia done
S0 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( F10)
时间窗: 10 minute after spinal anesthesia done
F10 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F30)
时间窗: 30 minute after spinal anesthesia done
F30 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F35)
时间窗: 35 minute after spinal anesthesia done
F35 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F40)
时间窗: 40 minute after spinal anesthesia done
F40 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F50)
时间窗: 50 minute after spinal anesthesia done
F50 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F55)
时间窗: 55 minute after spinal anesthesia done
F55 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S5)
时间窗: 5 minute after spinal anesthesia done
S5 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at ( F0)
时间窗: just after spinal anesthesia done
F0 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature( F2)
时间窗: 120 seconds after spinal anesthesia done
F2 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S8)
时间窗: 8 minute after spinal anesthesia done
S8 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S15)
时间窗: 15 minute after spinal anesthesia done
S15 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S25)
时间窗: 25 minute after spinal anesthesia done
S25 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S30)
时间窗: 30 minute after spinal anesthesia done
S30 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( F60)
时间窗: 60 minute after spinal anesthesia done
F60 will be defined as temperature which measured at C7 dermatome from palmar side of the 3rd finger with adult skin probe
peripheral skin temperature at( S2)
时间窗: 120 seconds after spinal anesthesia done
S2 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S7)
时间窗: 7 minute after spinal anesthesia done
S7 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S10)
时间窗: 10 minute after spinal anesthesia done
S10 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S3)
时间窗: 180 seconds after spinal anesthesia done
S3 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S6)
时间窗: 6 minute after spinal anesthesia done
S6 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S9)
时间窗: 9 minute after spinal anesthesia done
S9 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T3)
时间窗: 180 seconds after spinal anesthesia done
T3 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T5)
时间窗: 5 minute after spinal anesthesia done
T5 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T7)
时间窗: 7 minute after spinal anesthesia done
T7 will be defined as temperature which measured at L5 deramatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T20)
时间窗: 20 minute after spinal anesthesia done
T20 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T45)
时间窗: 45 minute after spinal anesthesia done
T45will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T55)
时间窗: 55 minute after spinal anesthesia done
T55 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M15)
时间窗: 15 minute after spinal anesthesia done
M15 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M40)
时间窗: 40 minute after spinal anesthesia done
M40 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature at( S35)
时间窗: 35 minute after spinal anesthesia done
S35 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature at( S40)
时间窗: 40 minute after spinal anesthesia done
S40 will be defined as temperature which measured at C6 dermatome from ventral side of styloid process with adult skin probe
peripheral skin temperature( T9)
时间窗: 9 minute after spinal anesthesia done
T9 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T50)
时间窗: 50 minute after spinal anesthesia done
T50 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M2)
时间窗: 120 seconds after spinal anesthesia done
M2 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M7)
时间窗: 7 minute after spinal anesthesia done
M7 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M8)
时间窗: 8 minute after spinal anesthesia done
M8 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M30)
时间窗: 30 minute after spinal anesthesia done
M30 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M35)
时间窗: 35 minute after spinal anesthesia done
M35 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M45)
时间窗: 45 minute after spinal anesthesia done
M45 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M50)
时间窗: 50 minute after spinal anesthesia done
M50 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M55)
时间窗: 55 minute after spinal anesthesia done
M55 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M60)
时间窗: 60 minute after spinal anesthesia done
M60 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( T6)
时间窗: 6 minute after spinal anesthesia done
T6 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T25)
时间窗: 25 minute after spinal anesthesia done
T25 will be defined as temperature which measured L5 dermatome at plantar side of 1st toe with adult skin probe
peripheral skin temperature( T60)
时间窗: 60 minute after spinal anesthesia done
T60 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M5)
时间窗: 5 minute after spinal anesthesia done
M5 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M6)
时间窗: 6 minute after spinal anesthesia done
M6 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( T10)
时间窗: 10 minute after spinal anesthesia done
T10 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T15)
时间窗: 15 minute after spinal anesthesia done
T15 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T30)
时间窗: 30 minute after spinal anesthesia done
T30 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M1)
时间窗: 60 seconds after spinal anesthesia done
M1 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M10)
时间窗: 10 minute after spinal anesthesia done
M10 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( T35)
时间窗: 35 minute after spinal anesthesia done
T35 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( T40)
时间窗: 40 minute after spinal anesthesia done
T40 will be defined as temperature which measured at L5 dermatome plantar side of 1st toe with adult skin probe
peripheral skin temperature( M3)
时间窗: 180 seconds after spinal anesthesia done
M3 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M4)
时间窗: 4 minute after spinal anesthesia done
M4 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M9)
时间窗: 9 minute after spinal anesthesia done
M9 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M20)
时间窗: 20 minute after spinal anesthesia done
M20 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
peripheral skin temperature( M25)
时间窗: 25 minute after spinal anesthesia done
M25 will be defined as temperature which measured at L4 dermatome above the medial malleolus with adult skin probe
次要结局
- shivering score(h0)(just before spinal anesthesia done)
- core tympanic membrane temperature (C0)(just before spinal anesthesia done)
- shivering score(h8)(120 minute after spinal anesthesia done)
- core tympanic membrane temperature(C2)(30 minute after spinal anesthesia done)
- core tympanic membrane temperature(C3)(45 minute after spinal anesthesia done)
- thermal comfort scale(Immediately after the surgery)
- core tympanic membrane temperature(C1)(15 minute after spinal anesthesia done)
- core tympanic membrane temperature(C4)(60 minute after spinal anesthesia done)
- shivering score(h6)(90 minute after spinal anesthesia done)
- shivering score(h1)(15 minute after spinal anesthesia done)
- shivering score(h2)(30 minute after spinal anesthesia done)
- shivering score(h3)(45 minute after spinal anesthesia done)
- shivering score(h4)(60 minute after spinal anesthesia done)
- shivering score(h5)(75 minute after spinal anesthesia done)
- shivering score(h7)(105 minute after spinal anesthesia done)
研究者
NEGIN NAYEBI
MD, Anesthesiology Resident
Bozyaka Training and Research Hospital