Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000375550
Ethics application status
Approved
Date submitted
21/01/2015
Date registered
23/04/2015
Date last updated
23/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of temperature change during operation of obesity.
Scientific title
Study to examine if anesthesia during laparoscopic abdominal surgery induces thermoregulatory response changes in the obese.
Secondary ID [1] 286021 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 293991 0
anesthesia 293992 0
Condition category
Condition code
Anaesthesiology 294287 294287 0 0
Other anaesthesiology
Diet and Nutrition 294748 294748 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
60 patients will be enrolled in the study with laparoscopic abdominal surgery under general anesthesia. Patients will be divided into two groups according to body mass index (Group I: if BMI is equal ot greater than 30 and Group II: if BMI is below than 24.9). In all cases, to avoid errors in body temperature measurements arising from the
diurnal rhythm, body temperature measurements were taken in the morning between 08:30 and 13:00 hours.
After preoxygenation with 100% O2, intravenous induction of anesthesia was obtained with 2-2,5 mg/kg propofol 0.6mg/kg rocuronium and 0.1 mcg/kg remifentanyl. After endotracheal intubation, anesthesia was maintained with 5-6% desflurane in 50% air-50% O2. Respiration was continued mechanically
and was adjusted to 30 to 40 mmHg ETCO2. In addition, to partially humidify and heat inhaled gases, a disposable humidifier was added to the breathing circuit. When necessary, patients were given additional doses of remifentanyl infusion and rocuronium. To remove the residual
muscle relaxant effects during recovery from anesthesia, 0.04 mg/kg neostigmine, and when required, 0.01 mg/kg intravenous atropine was used. When laryngeal reflexes and adequate spontaneous breathing returned, the patients were extubated.
The patients's temperature will follow every 5 minutes during operating room and postanesthetic care unit. Temperatures will record from central temperature, axillary, wrist, finger, thigh, cruris.
Intervention code [1] 291004 0
Not applicable
Comparator / control treatment
Control group will be generated from patients with normal body mass index (<24.9).
Control group
Active

Outcomes
Primary outcome [1] 294106 0
nasopharengeal temperature
(nasopharengeal temperature measured via anesthesia machine)
Timepoint [1] 294106 0
before anesthesia induction, in 5-minute intervals after the induction of
anesthesia, and in arrival to PACU
Primary outcome [2] 294107 0
mean skin temperature [0.3 (Tchest+Tarm) + 0.2 (Tthigh+Tcalf)]
(peripheral temperatures measured via anesthesia machine
thermometers)
Timepoint [2] 294107 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia until arrival to PACU.
Primary outcome [3] 294108 0
mean body temperature [0.64 x Tcentral + 0.36 x Tskin]
(tympanic temperature measured via infrared thermometer, but peripheral
temperatures measured via anesthesia machine thermometers)
Timepoint [3] 294108 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia until arrival to PACU
Secondary outcome [1] 312516 0
Shivering score (0: no shivering, 1: presence of one or more of such findings as piloerection, peripheral vasoconstriction, and peripheral cyanosis without muscle movement, 2: presence of muscle activity observable in single muscle group, 3: presence of muscle activity in more than one muscle group, 4: presence of significant muscle activity observed in the whole body)
Timepoint [1] 312516 0
On admission to post anesthetic care unit

Eligibility
Key inclusion criteria
The study was included 60 patients aged between 18-60 years whose physical status was in the American Society of Anesthesiologists (ASA) I-III risk group and were scheduled for laparoscopic abdominal surgery.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with inflammatory diseases, diabetes mellitus, muscle disease, hypo/hyperthyroidism, cardiac, hepatic and renal diseases, Parkinson disease, Reynold syndrome, a history of using drugs that are known to affect body temperature (Beta-blockers, calcium channel blockers,
clonidine, steroids, anti-epileptic, non-steroidal anti-inflammatory drugs, benzodiazepine), drug and alcohol addiction, obesity were excluded from the study. In addition,
patients whose surgery was shorter than 60 minutes and longer than 180 minutes were also excluded from the study. Patients having a greater than 30% change in
hemodynamic parameters during the surgery, those who needed to use a vasopressor or vasodilator, and those who required a blood transfusion were excluded from the study as well.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analyses will perform using IBM SPSS (Statistical Package for the Social Sciences) version 20. Data distribution was analyzed using the analysis of variance. Parametric data was expressed as the mean ± standard deviation. Following the assessment of age, weight, height, BMI, duration of surgery and all parametric data with variance analysis, an independent t test was used for between-group comparisons. Within-group comparisons were performed with paired sample t test. ASA risk class within the groups was assessed using chi-square test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/05/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6606 0
Turkey
State/province [1] 6606 0
Elazig

Funding & Sponsors
Funding source category [1] 290623 0
Self funded/Unfunded
Name [1] 290623 0
Country [1] 290623 0
Primary sponsor type
Individual
Name
Ayse Belin OZER
Address
Department of Anesthesiology and Reanimation, Firat University Medicine School, 23119, Elazig
Country
Turkey
Secondary sponsor category [1] 289308 0
None
Name [1] 289308 0
Address [1] 289308 0
Country [1] 289308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292251 0
Firat University Ethical Evaluation Commission Chairman
Ethics committee address [1] 292251 0
Ethics committee country [1] 292251 0
Turkey
Date submitted for ethics approval [1] 292251 0
24/12/2014
Approval date [1] 292251 0
13/01/2015
Ethics approval number [1] 292251 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54278 0
A/Prof Ayse Belin OZER
Address 54278 0
Firat University Medicine Faculty Anesthesiology and Reanimation
Department 23119, Elazig
Country 54278 0
Turkey
Phone 54278 0
+90 533 4478924
Fax 54278 0
+90 424 2388096
Email 54278 0
[email protected]
Contact person for public queries
Name 54279 0
Ayse Belin OZER
Address 54279 0
Firat University Medicine Faculty Anesthesiology and Reanimation
Department 23119, Elazig
Country 54279 0
Turkey
Phone 54279 0
+ 90 533 447 8924
Fax 54279 0
+90 424 2388096
Email 54279 0
[email protected]
Contact person for scientific queries
Name 54280 0
Ayse Beklin OZER
Address 54280 0
Firat University Medicine Faculty Anesthesiology and Reanimation
Department 23119, Elazig
Country 54280 0
Turkey
Phone 54280 0
+90 533 4478924
Fax 54280 0
+90 424 2388096
Email 54280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effect of body mass index on perioperative thermoregulation2016https://doi.org/10.2147/tcrm.s122700
N.B. These documents automatically identified may not have been verified by the study sponsor.