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Trial registered on ANZCTR


Registration number
ACTRN12616000795493
Ethics application status
Approved
Date submitted
24/05/2016
Date registered
17/06/2016
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of isothermic irrigation on preservation of body temperature in endoscopic ureteral stone surgery under spinal anesthesia
Scientific title
Role of isothermic irrigation on preservation of body temperature in endoscopic ureteral stone surgery under spinal anesthesia
Secondary ID [1] 289284 0
none
Universal Trial Number (UTN)
U1111-1181-2982
Trial acronym
IIEUSSBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preservation of body temperature in ureteral stone surgery under spinal anesthesia 298869 0
Condition category
Condition code
Renal and Urogenital 298940 298940 0 0
Other renal and urogenital disorders
Anaesthesiology 298941 298941 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
the patients were randomly divided into two groups by sealed envelope technique. the irrigation fluid was given at room temperature to the control group and the irrigation fluid for the study group was at body temperature. the irrigation fluid was heated by an incubator set at 37 celcius degrees and was protected in a non permenant heat protecting bag. The temperature of the irrigation solution was controlled by a digital thermometer by the study stuff. Room temperature, patient's body temperature were recorded before spinal anesthesia. Spinal anesthesia was performed by an anesthesiologist who was unaware of the heat of the irrigation fluid at L4-L5 interspace with 15mg 0.5% hyperbaric bupivacaine. the body temperature and the hemodynamic parameters were recorded each minute for the first 10 minutes and at 5 minute intervals till 30 minute after spinal anesthesia and at the end of the operation. the spinal anesthesia was monitored with loss of sensation to pinprick test at midclavicular line and recorded at the same time points with temperature measurements.
Intervention code [1] 294833 0
Treatment: Surgery
Intervention code [2] 294834 0
Prevention
Comparator / control treatment
Irrigation at room temperature was the control group, which is the standard care. The room temperature is set at 21 degrees celcius and monitored by a thermometer continiously.
Control group
Active

Outcomes
Primary outcome [1] 298408 0
Body temperature of the patient was monitored with a tympanic digital thermometer.
Timepoint [1] 298408 0
measurement time points started with the patients' entering to operation room which was basal body temperature and continued each minute for 10 minutes after spinal anesthesia and every 5 minutes till 30 minutes after spinal anesthesia and at the end of the operation
Secondary outcome [1] 324046 0
affect of irrigation fluid temperature on surgical comfort is assessed by a questionare completed by the surgeon (1: worse than conventional , 0: there is no difference when compared to cenventional technique, 2: better than conventional technique) at the end of the surgery. conventional technique is the technique regularly used for this surgery in our clinic before the study.
Timepoint [1] 324046 0
At the end of the surgery
Secondary outcome [2] 324047 0
affect of irrigation fluid temperature on shivering of the patient. Shivering is assessed by the study staff with a scale (0: no shivering, 1: no shivering but piloerection and/or vasoconstriction present, 2: muscle activity at single muscle group, 3: muscle activity at more than one muscle group, 4: total body shivering)
Timepoint [2] 324047 0
assessment of shivering started with the induction of anesthesia till the end of surgical procedure every minute for the first 10 minutes and with 5 minutes interval till the end of surgery.
Secondary outcome [3] 324048 0
the correlation between irrigation fluid volume and the body temperature measured by a tympanic digital thermometer will be assessed by correlation tests.total amount of irrigation will be documented at the end of surgery by the study staff.
Timepoint [3] 324048 0
amount of irrigation will be recorded at the end of surgery. tympanic measurement of body temperature by a digital thermometer will start with the entrance of the patient to the operation room and will continue each minute for 10 minutes after spinal anesthesia and for 5 minute intervals till the end of surgery.

Eligibility
Key inclusion criteria
patients consenting to spinal anesthesia for endoscopic ureteral stone treatment surgery
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients rejecting spinal anesthesia or any contraindication for spinal anesthesia

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis
G*power statistical analysis program will be used to determine the sample size for 90% power and 0.05 statistical significance. Kolmogorov-Smirnow and Shapiro-Wilk tests will be used for determining normal data distribution. Repeated measures ANOVA, Friedman test, Chi-square, Friedman test, Spearman's Rho Correlation tests will be used. statistical significance is accepted as 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
3/08/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
28/12/2016
Date of last data collection
Anticipated
Actual
28/12/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7894 0
Turkey
State/province [1] 7894 0
kirsehir

Funding & Sponsors
Funding source category [1] 293661 0
Self funded/Unfunded
Name [1] 293661 0
mehmet canturk
Country [1] 293661 0
Turkey
Primary sponsor type
Individual
Name
Mehmet Canturk
Address
Medical doctor at government hospital
asikpasa mahallesi
sehit ahmet dogangun caddesi
caglar apartmani
30/8
merkez/kirsehir/Turkey p.k.40100
Country
Turkey
Secondary sponsor category [1] 292496 0
None
Name [1] 292496 0
Address [1] 292496 0
Country [1] 292496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295100 0
Turgut Ozal University Clinical Trials Ethics Committee
Ethics committee address [1] 295100 0
Ethics committee country [1] 295100 0
Date submitted for ethics approval [1] 295100 0
29/04/2016
Approval date [1] 295100 0
23/05/2016
Ethics approval number [1] 295100 0
99950669/115

Summary
Brief summary
Thermoregulation is one of the major problems affecting both morbidity and mortality of the patients undergoing either general anesthesia or regional anesthesia. in general, monitorisation of body temperature is neglected for the operations lasting no more than two hours. in this randomised controlled clinical trial we hypothesised that isothermic irrigation will prevent the patient from hypothermia with respect to irrigation at room temperature resulting in preservation of body temperature and an increased surgeon satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62834 0
Dr Mehmet Canturk
Address 62834 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3.Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 p.k. 40100 kirsehir
Country 62834 0
Turkey
Phone 62834 0
+905053574372
Fax 62834 0
Email 62834 0
[email protected]
Contact person for public queries
Name 62835 0
Mehmet Canturk
Address 62835 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3.Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 p.k.40100 kirsehir
Country 62835 0
Turkey
Phone 62835 0
+905053574372
Fax 62835 0
Email 62835 0
[email protected]
Contact person for scientific queries
Name 62836 0
Mehmet Canturk
Address 62836 0
Kirsehir Ahi Evran Universitesi Egitim ve Arastirma Hastanesi 3.Kat Ameliyathane Kervansaray Mahallesi 2019. sokak no:1 p.k. 40100 kirsehir
Country 62836 0
Turkey
Phone 62836 0
+905053574372
Fax 62836 0
Email 62836 0
[email protected]

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