Effect of Prewarming On Skin Temperature Changes

NCT05063292 | Unknown DMC

• 1 other identifier: NeginIzmirBozyaka
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Hypothermia Following Anesthesia; Prewarming; Core Temperature; Urological Cancer

Keywords

hypothermia; peripheral temperature; spinal anesthesia; forced-air warming

Outcome Measures

Primary Outcomes (84)

• 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 Outcomes (15)

• core tympanic membrane temperature (C0)

  just before spinal anesthesia done

• core tympanic membrane temperature(C1)

  15 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

• core tympanic membrane temperature(C4)

  60 minute after spinal anesthesia done

Study Arms (2)

Control group

NO INTERVENTION

Patients covered with a 41 centigrade degrees double layered cotton cloth

Prewarmed group

EXPERIMENTAL

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

Interventions

Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation PROCEDURE

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.

Prewarmed group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: Male patients scheduled for transurethral bladder resection
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II-III
• years old
• Patients scheduled for transurethral baldder resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Bozyaka Training and Research Hospital

Izmir, Karabağlar, 35170, Turkey (Türkiye)

Location

Related Publications (6)

• Hermanns H, Werdehausen R, Hollmann MW, Stevens MF. Assessment of skin temperature during regional anaesthesia-What the anaesthesiologist should know. Acta Anaesthesiol Scand. 2018 Oct;62(9):1280-1289. doi: 10.1111/aas.13176. Epub 2018 Jun 25.

  PMID: 29938773 BACKGROUND

• Jun JH, Chung MH, Kim EM, Jun IJ, Kim JH, Hyeon JS, Lee MH, Lee HS, Choi EM. Effect of pre-warming on perioperative hypothermia during holmium laser enucleation of the prostate under spinal anesthesia: a prospective randomized controlled trial. BMC Anesthesiol. 2018 Dec 22;18(1):201. doi: 10.1186/s12871-018-0668-4.

  PMID: 30579334 BACKGROUND

• Fradkin AJ, Zazryn TR, Smoliga JM. Effects of warming-up on physical performance: a systematic review with meta-analysis. J Strength Cond Res. 2010 Jan;24(1):140-8. doi: 10.1519/JSC.0b013e3181c643a0.

  PMID: 19996770 BACKGROUND

• Frank SM, El-Rahmany HK, Tran KM, Vu B, Raja SN. Comparison of lower extremity cutaneous temperature changes in patients receiving lumbar sympathetic ganglion blocks versus epidural anesthesia. J Clin Anesth. 2000 Nov;12(7):525-30. doi: 10.1016/s0952-8180(00)00207-5.

  PMID: 11137413 BACKGROUND

• Jo YY, Chang YJ, Kim YB, Lee S, Kwak HJ. Effect of Preoperative Forced-Air Warming on Hypothermia in Elderly Patients Undergoing Transurethral Resection of the Prostate. Urol J. 2015 Nov 14;12(5):2366-70.

  PMID: 26571323 BACKGROUND

• Nayebi N, Tekgul ZT, Sahinkaya HH. Effect of Prewarming on Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of the Bladder. J Perianesth Nurs. 2024 Jun;39(3):391-396. doi: 10.1016/j.jopan.2023.08.020. Epub 2024 Jan 11.

  PMID: 38206216 DERIVED

MeSH Terms

Conditions

Urologic Neoplasms; Hypothermia

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Halide Hande Şahinkaya, Specialist

  Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

Central Study Contacts

Negin Nayebi, MD

CONTACT

+905541491707; negin.naebi@gmail.com

Zeki Tuncel Tekgül, Assoc Prof

CONTACT

+905058554705; zekitekgul@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiology Resident

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: October 1, 2021
• Study Start: October 5, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 18, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)