Clinical trial NCT05063292: Effect of Prewarming On Skin Temperature Changes
Official title: Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Anesthesia
Hypothermia Following Anesthesia
Prewarming
Core Temperature
Urological Cancer
Keywords: hypothermia
peripheral temperature
spinal anesthesia
forced-air warming
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: peripheral skin temperature at ( F0)
timeFrame: just after spinal anesthesia done
measure: peripheral skin temperature at( S0)
timeFrame: just after spinal anesthesia done
measure: peripheral skin temperature( T0)
timeFrame: just after spinal anesthesia done
measure: peripheral skin temperature( M0)
timeFrame: just after spinal anesthesia done
measure: peripheral skin temperature( F1)
timeFrame: 60 seconds after spinal anesthesia done
measure: peripheral skin temperature( F2)
timeFrame: 120 seconds after spinal anesthesia done
measure: peripheral skin temperature( F3)
timeFrame: 180 seconds after spinal anesthesia done
measure: peripheral skin temperature( F4)
timeFrame: 4 minute after spinal anesthesia done
measure: peripheral skin temperature( F5)
timeFrame: 5 minute after spinal anesthesia done
measure: peripheral skin temperature( F6)
timeFrame: 6 minute after spinal anesthesia done
measure: peripheral skin temperature( F7)
timeFrame: 7 minute after spinal anesthesia done
measure: peripheral skin temperature( F8)
timeFrame: 8 minute after spinal anesthesia done
measure: peripheral skin temperature( F9)
timeFrame: 9 minute after spinal anesthesia done
measure: peripheral skin temperature( F10)
timeFrame: 10 minute after spinal anesthesia done
measure: peripheral skin temperature( F15)
timeFrame: 15 minute after spinal anesthesia done
measure: peripheral skin temperature( F20)
timeFrame: 20 minute after spinal anesthesia done
measure: peripheral skin temperature( F25)
timeFrame: 25 minute after spinal anesthesia done
measure: peripheral skin temperature( F30)
timeFrame: 30 minute after spinal anesthesia done
measure: peripheral skin temperature( F35)
timeFrame: 35 minute after spinal anesthesia done
measure: peripheral skin temperature( F40)
timeFrame: 40 minute after spinal anesthesia done
measure: peripheral skin temperature( F45)
timeFrame: 45 minute after spinal anesthesia done
measure: peripheral skin temperature( F50)
timeFrame: 50 minute after spinal anesthesia done
measure: peripheral skin temperature( F55)
timeFrame: 55 minute after spinal anesthesia done
measure: peripheral skin temperature( F60)
timeFrame: 60 minute after spinal anesthesia done
measure: peripheral skin temperature at( S1)
timeFrame: 60 seconds after spinal anesthesia done
measure: peripheral skin temperature at( S2)
timeFrame: 120 seconds after spinal anesthesia done
measure: peripheral skin temperature at( S3)
timeFrame: 180 seconds after spinal anesthesia done
measure: peripheral skin temperature at( S4)
timeFrame: 4 minute after spinal anesthesia done
measure: peripheral skin temperature at( S5)
timeFrame: 5 minute after spinal anesthesia done
measure: peripheral skin temperature at( S6)
timeFrame: 6 minute after spinal anesthesia done
measure: peripheral skin temperature at( S7)
timeFrame: 7 minute after spinal anesthesia done
measure: peripheral skin temperature at( S8)
timeFrame: 8 minute after spinal anesthesia done
measure: peripheral skin temperature at( S9)
timeFrame: 9 minute after spinal anesthesia done
measure: peripheral skin temperature at( S10)
timeFrame: 10 minute after spinal anesthesia done
measure: peripheral skin temperature at( S15)
timeFrame: 15 minute after spinal anesthesia done
measure: peripheral skin temperature at( S20)
timeFrame: 20 minute after spinal anesthesia done
measure: peripheral skin temperature at( S25)
timeFrame: 25 minute after spinal anesthesia done
measure: peripheral skin temperature at( S30)
timeFrame: 30 minute after spinal anesthesia done
measure: peripheral skin temperature at( S35)
timeFrame: 35 minute after spinal anesthesia done
measure: peripheral skin temperature at( S40)
timeFrame: 40 minute after spinal anesthesia done
measure: peripheral skin temperature at( S45)
timeFrame: 45 minute after spinal anesthesia done
measure: peripheral skin temperature at( S50)
timeFrame: 50 minute after spinal anesthesia done
measure: peripheral skin temperature at( S55)
timeFrame: 55 minute after spinal anesthesia done
measure: peripheral skin temperature at( S60)
timeFrame: 60 minute after spinal anesthesia done
measure: peripheral skin temperature( T1)
timeFrame: 60 seconds after spinal anesthesia done
measure: peripheral skin temperature( T2)
timeFrame: 120 seconds after spinal anesthesia done
measure: peripheral skin temperature( T3)
timeFrame: 180 seconds after spinal anesthesia done
measure: peripheral skin temperature( T4)
timeFrame: 4 minute after spinal anesthesia done
measure: peripheral skin temperature( T5)
timeFrame: 5 minute after spinal anesthesia done
measure: peripheral skin temperature( T6)
timeFrame: 6 minute after spinal anesthesia done
measure: peripheral skin temperature( T7)
timeFrame: 7 minute after spinal anesthesia done
measure: peripheral skin temperature( T8)
timeFrame: 8 minute after spinal anesthesia done
measure: peripheral skin temperature( T9)
timeFrame: 9 minute after spinal anesthesia done
measure: peripheral skin temperature( T10)
timeFrame: 10 minute after spinal anesthesia done
measure: peripheral skin temperature( T15)
timeFrame: 15 minute after spinal anesthesia done
measure: peripheral skin temperature( T20)
timeFrame: 20 minute after spinal anesthesia done
measure: peripheral skin temperature( T25)
timeFrame: 25 minute after spinal anesthesia done
measure: peripheral skin temperature( T30)
timeFrame: 30 minute after spinal anesthesia done
measure: peripheral skin temperature( T35)
timeFrame: 35 minute after spinal anesthesia done
measure: peripheral skin temperature( T40)
timeFrame: 40 minute after spinal anesthesia done
measure: peripheral skin temperature( T45)
timeFrame: 45 minute after spinal anesthesia done
measure: peripheral skin temperature( T50)
timeFrame: 50 minute after spinal anesthesia done
measure: peripheral skin temperature( T55)
timeFrame: 55 minute after spinal anesthesia done
measure: peripheral skin temperature( T60)
timeFrame: 60 minute after spinal anesthesia done
measure: peripheral skin temperature( M1)
timeFrame: 60 seconds after spinal anesthesia done
measure: peripheral skin temperature( M2)
timeFrame: 120 seconds after spinal anesthesia done
measure: peripheral skin temperature( M3)
timeFrame: 180 seconds after spinal anesthesia done
measure: peripheral skin temperature( M4)
timeFrame: 4 minute after spinal anesthesia done
measure: peripheral skin temperature( M5)
timeFrame: 5 minute after spinal anesthesia done
measure: peripheral skin temperature( M6)
timeFrame: 6 minute after spinal anesthesia done
measure: peripheral skin temperature( M7)
timeFrame: 7 minute after spinal anesthesia done
measure: peripheral skin temperature( M8)
timeFrame: 8 minute after spinal anesthesia done
measure: peripheral skin temperature( M9)
timeFrame: 9 minute after spinal anesthesia done
measure: peripheral skin temperature( M10)
timeFrame: 10 minute after spinal anesthesia done
measure: peripheral skin temperature( M15)
timeFrame: 15 minute after spinal anesthesia done
measure: peripheral skin temperature( M20)
timeFrame: 20 minute after spinal anesthesia done
measure: peripheral skin temperature( M25)
timeFrame: 25 minute after spinal anesthesia done
measure: peripheral skin temperature( M30)
timeFrame: 30 minute after spinal anesthesia done
measure: peripheral skin temperature( M35)
timeFrame: 35 minute after spinal anesthesia done
measure: peripheral skin temperature( M40)
timeFrame: 40 minute after spinal anesthesia done
measure: peripheral skin temperature( M45)
timeFrame: 45 minute after spinal anesthesia done
measure: peripheral skin temperature( M50)
timeFrame: 50 minute after spinal anesthesia done
measure: peripheral skin temperature( M55)
timeFrame: 55 minute after spinal anesthesia done
measure: peripheral skin temperature( M60)
timeFrame: 60 minute after spinal anesthesia done
Secondary outcomes:
measure: core tympanic membrane temperature (C0)
timeFrame: just before spinal anesthesia done
measure: core tympanic membrane temperature(C1)
timeFrame: 15 minute after spinal anesthesia done
measure: core tympanic membrane temperature(C2)
timeFrame: 30 minute after spinal anesthesia done
measure: core tympanic membrane temperature(C3)
timeFrame: 45 minute after spinal anesthesia done
measure: core tympanic membrane temperature(C4)
timeFrame: 60 minute after spinal anesthesia done
measure: thermal comfort scale
timeFrame: Immediately after the surgery
measure: shivering score(h0)
timeFrame: just before spinal anesthesia done
measure: shivering score(h1)
timeFrame: 15 minute after spinal anesthesia done
measure: shivering score(h2)
timeFrame: 30 minute after spinal anesthesia done
measure: shivering score(h3)
timeFrame: 45 minute after spinal anesthesia done
measure: shivering score(h4)
timeFrame: 60 minute after spinal anesthesia done
measure: shivering score(h5)
timeFrame: 75 minute after spinal anesthesia done
measure: shivering score(h6)
timeFrame: 90 minute after spinal anesthesia done
measure: shivering score(h7)
timeFrame: 105 minute after spinal anesthesia done
measure: shivering score(h8)
timeFrame: 120 minute after spinal anesthesia done
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Bozyaka Training and Research Hospital
state: Karabağlar
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Halide Hande Şahinkaya, Specialist
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.