- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05063292
Effect of Prewarming On Skin Temperature Changes
September 27, 2021 updated by: NEGIN NAYEBI, Bozyaka Training and Research Hospital
Effect of Prewarming On Skin Temperature Changes After Spinal Anesthesia in Transurethral Resection of The Bladder
In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups.
First group will be covered with 41 centigrade degrees double layered cotton cloth.
Second group will receive active prewarming.
Core temperature of all patients will be monitorized via tympanic membrane.
Skin temperature will be monitorized from 4 different body areas.
Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine.
Pinprick test will be used for sensorial block assessment.
T10 sensorial block will be our goal.
Hemodynamic parameters will be recorded.
Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded.
Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded.
Shivering score and thermal comfort scale will be used.
The two groups will be compared for the temperature changes.
Study Overview
Status
Not yet recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Negin Nayebi, MD
- Phone Number: +905541491707
- Email: negin.naebi@gmail.com
Study Contact Backup
- Name: Zeki Tuncel Tekgül, Assoc Prof
- Phone Number: +905058554705
- Email: zekitekgul@yahoo.com
Study Locations
-
-
Karabağlar
-
İzmir, Karabağlar, Turkey, 35170
- Bozyaka Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Patients covered with a 41 centigrade degrees double layered cotton cloth
|
|
Experimental: Prewarmed group
Patients receive active prewarming with an air forced blanket ( full body blanket) 30 minutes prior to the operation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peripheral skin temperature at ( F0)
Time Frame: 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
|
just after spinal anesthesia done
|
peripheral skin temperature at( S0)
Time Frame: 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
|
just after spinal anesthesia done
|
peripheral skin temperature( T0)
Time Frame: 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
|
just after spinal anesthesia done
|
peripheral skin temperature( M0)
Time Frame: just after spinal anesthesia done
|
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)
Time Frame: 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
|
60 seconds after spinal anesthesia done
|
peripheral skin temperature( F2)
Time Frame: 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
|
120 seconds after spinal anesthesia done
|
peripheral skin temperature( F3)
Time Frame: 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
|
180 seconds after spinal anesthesia done
|
peripheral skin temperature( F4)
Time Frame: 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
|
4 minute after spinal anesthesia done
|
peripheral skin temperature( F5)
Time Frame: 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
|
5 minute after spinal anesthesia done
|
peripheral skin temperature( F6)
Time Frame: 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
|
6 minute after spinal anesthesia done
|
peripheral skin temperature( F7)
Time Frame: 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
|
7 minute after spinal anesthesia done
|
peripheral skin temperature( F8)
Time Frame: 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
|
8 minute after spinal anesthesia done
|
peripheral skin temperature( F9)
Time Frame: 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
|
9 minute after spinal anesthesia done
|
peripheral skin temperature( F10)
Time Frame: 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
|
10 minute after spinal anesthesia done
|
peripheral skin temperature( F15)
Time Frame: 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
|
15 minute after spinal anesthesia done
|
peripheral skin temperature( F20)
Time Frame: 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
|
20 minute after spinal anesthesia done
|
peripheral skin temperature( F25)
Time Frame: 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
|
25 minute after spinal anesthesia done
|
peripheral skin temperature( F30)
Time Frame: 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
|
30 minute after spinal anesthesia done
|
peripheral skin temperature( F35)
Time Frame: 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
|
35 minute after spinal anesthesia done
|
peripheral skin temperature( F40)
Time Frame: 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
|
40 minute after spinal anesthesia done
|
peripheral skin temperature( F45)
Time Frame: 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
|
45 minute after spinal anesthesia done
|
peripheral skin temperature( F50)
Time Frame: 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
|
50 minute after spinal anesthesia done
|
peripheral skin temperature( F55)
Time Frame: 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
|
55 minute after spinal anesthesia done
|
peripheral skin temperature( F60)
Time Frame: 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
|
60 minute after spinal anesthesia done
|
peripheral skin temperature at( S1)
Time Frame: 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
|
60 seconds after spinal anesthesia done
|
peripheral skin temperature at( S2)
Time Frame: 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
|
120 seconds after spinal anesthesia done
|
peripheral skin temperature at( S3)
Time Frame: 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
|
180 seconds after spinal anesthesia done
|
peripheral skin temperature at( S4)
Time Frame: 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
|
4 minute after spinal anesthesia done
|
peripheral skin temperature at( S5)
Time Frame: 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
|
5 minute after spinal anesthesia done
|
peripheral skin temperature at( S6)
Time Frame: 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
|
6 minute after spinal anesthesia done
|
peripheral skin temperature at( S7)
Time Frame: 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
|
7 minute after spinal anesthesia done
|
peripheral skin temperature at( S8)
Time Frame: 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
|
8 minute after spinal anesthesia done
|
peripheral skin temperature at( S9)
Time Frame: 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
|
9 minute after spinal anesthesia done
|
peripheral skin temperature at( S10)
Time Frame: 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
|
10 minute after spinal anesthesia done
|
peripheral skin temperature at( S15)
Time Frame: 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
|
15 minute after spinal anesthesia done
|
peripheral skin temperature at( S20)
Time Frame: 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
|
20 minute after spinal anesthesia done
|
peripheral skin temperature at( S25)
Time Frame: 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
|
25 minute after spinal anesthesia done
|
peripheral skin temperature at( S30)
Time Frame: 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
|
30 minute after spinal anesthesia done
|
peripheral skin temperature at( S35)
Time Frame: 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
|
35 minute after spinal anesthesia done
|
peripheral skin temperature at( S40)
Time Frame: 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
|
40 minute after spinal anesthesia done
|
peripheral skin temperature at( S45)
Time Frame: 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
|
45 minute after spinal anesthesia done
|
peripheral skin temperature at( S50)
Time Frame: 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
|
50 minute after spinal anesthesia done
|
peripheral skin temperature at( S55)
Time Frame: 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
|
55 minute after spinal anesthesia done
|
peripheral skin temperature at( S60)
Time Frame: 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
|
60 minute after spinal anesthesia done
|
peripheral skin temperature( T1)
Time Frame: 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
|
60 seconds after spinal anesthesia done
|
peripheral skin temperature( T2)
Time Frame: 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
|
120 seconds after spinal anesthesia done
|
peripheral skin temperature( T3)
Time Frame: 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
|
180 seconds after spinal anesthesia done
|
peripheral skin temperature( T4)
Time Frame: 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
|
4 minute after spinal anesthesia done
|
peripheral skin temperature( T5)
Time Frame: 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
|
5 minute after spinal anesthesia done
|
peripheral skin temperature( T6)
Time Frame: 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
|
6 minute after spinal anesthesia done
|
peripheral skin temperature( T7)
Time Frame: 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
|
7 minute after spinal anesthesia done
|
peripheral skin temperature( T8)
Time Frame: 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
|
8 minute after spinal anesthesia done
|
peripheral skin temperature( T9)
Time Frame: 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
|
9 minute after spinal anesthesia done
|
peripheral skin temperature( T10)
Time Frame: 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
|
10 minute after spinal anesthesia done
|
peripheral skin temperature( T15)
Time Frame: 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
|
15 minute after spinal anesthesia done
|
peripheral skin temperature( T20)
Time Frame: 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
|
20 minute after spinal anesthesia done
|
peripheral skin temperature( T25)
Time Frame: 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
|
25 minute after spinal anesthesia done
|
peripheral skin temperature( T30)
Time Frame: 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
|
30 minute after spinal anesthesia done
|
peripheral skin temperature( T35)
Time Frame: 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
|
35 minute after spinal anesthesia done
|
peripheral skin temperature( T40)
Time Frame: 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
|
40 minute after spinal anesthesia done
|
peripheral skin temperature( T45)
Time Frame: 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
|
45 minute after spinal anesthesia done
|
peripheral skin temperature( T50)
Time Frame: 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
|
50 minute after spinal anesthesia done
|
peripheral skin temperature( T55)
Time Frame: 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
|
55 minute after spinal anesthesia done
|
peripheral skin temperature( T60)
Time Frame: 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
|
60 minute after spinal anesthesia done
|
peripheral skin temperature( M1)
Time Frame: 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
|
60 seconds after spinal anesthesia done
|
peripheral skin temperature( M2)
Time Frame: 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
|
120 seconds after spinal anesthesia done
|
peripheral skin temperature( M3)
Time Frame: 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
|
180 seconds after spinal anesthesia done
|
peripheral skin temperature( M4)
Time Frame: 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
|
4 minute after spinal anesthesia done
|
peripheral skin temperature( M5)
Time Frame: 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
|
5 minute after spinal anesthesia done
|
peripheral skin temperature( M6)
Time Frame: 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
|
6 minute after spinal anesthesia done
|
peripheral skin temperature( M7)
Time Frame: 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
|
7 minute after spinal anesthesia done
|
peripheral skin temperature( M8)
Time Frame: 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
|
8 minute after spinal anesthesia done
|
peripheral skin temperature( M9)
Time Frame: 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
|
9 minute after spinal anesthesia done
|
peripheral skin temperature( M10)
Time Frame: 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
|
10 minute after spinal anesthesia done
|
peripheral skin temperature( M15)
Time Frame: 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
|
15 minute after spinal anesthesia done
|
peripheral skin temperature( M20)
Time Frame: 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
|
20 minute after spinal anesthesia done
|
peripheral skin temperature( M25)
Time Frame: 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
|
25 minute after spinal anesthesia done
|
peripheral skin temperature( M30)
Time Frame: 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
|
30 minute after spinal anesthesia done
|
peripheral skin temperature( M35)
Time Frame: 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
|
35 minute after spinal anesthesia done
|
peripheral skin temperature( M40)
Time Frame: 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
|
40 minute after spinal anesthesia done
|
peripheral skin temperature( M45)
Time Frame: 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
|
45 minute after spinal anesthesia done
|
peripheral skin temperature( M50)
Time Frame: 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
|
50 minute after spinal anesthesia done
|
peripheral skin temperature( M55)
Time Frame: 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
|
55 minute after spinal anesthesia done
|
peripheral skin temperature( M60)
Time Frame: 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
|
60 minute after spinal anesthesia done
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
core tympanic membrane temperature (C0)
Time Frame: just before spinal anesthesia done
|
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)
Time Frame: 15 minute after spinal anesthesia done
|
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)
Time Frame: 30 minute after spinal anesthesia done
|
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)
Time Frame: 45 minute after spinal anesthesia done
|
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)
Time Frame: 60 minute after spinal anesthesia done
|
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
Time Frame: Immediately after the surgery
|
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)
Time Frame: just before spinal anesthesia done
|
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)
Time Frame: 15 minute after spinal anesthesia done
|
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)
Time Frame: 30 minute after spinal anesthesia done
|
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)
Time Frame: 45 minute after spinal anesthesia done
|
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)
Time Frame: 60 minute after spinal anesthesia done
|
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)
Time Frame: 75 minute after spinal anesthesia done
|
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)
Time Frame: 90 minute after spinal anesthesia done
|
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)
Time Frame: 105 minute after spinal anesthesia done
|
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)
Time Frame: 120 minute after spinal anesthesia done
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Halide Hande Şahinkaya, Specialist, Izmir Bozyaka Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 5, 2021
Primary Completion (Anticipated)
November 10, 2021
Study Completion (Anticipated)
November 18, 2021
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 27, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Actual)
October 1, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NeginIzmirBozyaka
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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