Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000792820
Ethics application status
Approved
Date submitted
23/07/2012
Date registered
26/07/2012
Date last updated
27/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of preoperative oral carbohydrate solution intake on thermoregulation
Scientific title
Effects of preoperative oral carbohydrate solution intake on thermoregulation in female patients undergoing myomectomy-hysterectomy under general anesthesia
Secondary ID [1] 280901 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anesthesia 286979 0
thermoregulation 286980 0
preoperative diet 286981 0
Condition category
Condition code
Anaesthesiology 287316 287316 0 0
Anaesthetics
Diet and Nutrition 287317 287317 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were randomly divided into two groups. Group C (control group, n=20): included patients who oral intake stopped 8 hours before operation and Group CH (preoperative carbohydrate group, n=20): patients that were administered oral carbohydrate fluid (12.6 %, 50 kcal per 100 ml fluid) prepared for preoperative period as 800 ml to be administered 8 hours before the operation and as 400 ml 2 hours before the operation.
Intervention code [1] 285331 0
Prevention
Intervention code [2] 285334 0
Treatment: Other
Comparator / control treatment
Group C (control group, n=20): included patients who oral intake stopped 8 hours before operation
Control group
Active

Outcomes
Primary outcome [1] 287591 0
tympanic temperature
(for tympanic membrane injury was prevented, tympanic temperature measured via infrared thermometer)
Timepoint [1] 287591 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia, and in 10-minute intervals in PACU,
during one hour in PACU
Primary outcome [2] 287592 0
mean skin temperature [0.3 (Tchest+Tarm) + 0.2 (Tthigh+Tcalf)]
(peripheral temperatures measured via anesthesia machine thermometers)
Timepoint [2] 287592 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia, and in 10-minute intervals in PACU, during one hour in PACU
Primary outcome [3] 287593 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] 287593 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia, and in 10-minute intervals in PACU, during one hour in PACU
Secondary outcome [1] 298484 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] 298484 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia, and in 10-minute intervals in PACU, during one hour in PACU
Secondary outcome [2] 298486 0
vasoconstriction threshold
(Vasoconstriction was estimated with the [Tforearm- Tfingertip] formula of fingertip blood flow and the obtained value '0' demonstrates the vasoconstriction initiated and the value 4 shows severe vasoconstriction. Central temperature at the time of vasoconstriction formation shows us the vasoconstriction threshold)
Timepoint [2] 298486 0
before anesthesia induction, in 5-minute intervals after the induction of anesthesia, and in 10-minute intervals in PACU, during one hour in PACU

Eligibility
Key inclusion criteria
The study included 40 female patients who were to undergo myomectomy-hysterectomy under general anesthesia with ages ranging between 18 and 50 year and that have I-II ASA physical status classification patients were chosen from among the cases to undergo operation between the hours 08:00 am and 13:00 pm.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that had an inflammatory disease, diabetes mellitus, muscle diseases, hypo-hyperthyroidism, Parkinson disease, Raynaud phenomenon, with body mass index below 20 and above 30, used drug affecting body temperature (beta-blocker, calcium channel blocker, clonidine, steroid, antiepileptic, NSAI, benzodiazepine) and delayed gastric emptying (pregnancy, gastroesophageal reflux, opioid use) were excluded from the study. In addition, patients that will undergo an operation that takes less than 60 minutes or more than 180 minutes were not included in the study. Patients that had alterations in their hemodynamic parameters more than 30%, patients that required the use of vasopressor or vasodilator, and patients needed blood transfusion were excluded from the study.

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 opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4422 0
Turkey
State/province [1] 4422 0

Funding & Sponsors
Funding source category [1] 285693 0
Self funded/Unfunded
Name [1] 285693 0
Country [1] 285693 0
Primary sponsor type
Individual
Name
Ayse Belin OZER
Address
Department of Anesthesiology and Reanimation, Firat University, 23119, Elazig
Country
Turkey
Secondary sponsor category [1] 284521 0
None
Name [1] 284521 0
Address [1] 284521 0
Country [1] 284521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287690 0
Firat University Medical School Ethical Evaluation Commission Chairman
Ethics committee address [1] 287690 0
Ethics committee country [1] 287690 0
Turkey
Date submitted for ethics approval [1] 287690 0
07/02/2011
Approval date [1] 287690 0
10/03/2011
Ethics approval number [1] 287690 0

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

Contacts
Principal investigator
Name 34480 0
Address 34480 0
Country 34480 0
Phone 34480 0
Fax 34480 0
Email 34480 0
Contact person for public queries
Name 17727 0
Ayse Belin OZER
Address 17727 0
Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119, Elazig
Country 17727 0
Turkey
Phone 17727 0
+90 424 533 4478924
Fax 17727 0
+90 424 2388096
Email 17727 0
[email protected]
Contact person for scientific queries
Name 8655 0
Ayse Belin OZER
Address 8655 0
Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119, Elazig
Country 8655 0
Turkey
Phone 8655 0
+90 424 533 4478924
Fax 8655 0
+90 424 2388096
Email 8655 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 AIEffects of preoperative oral carbohydrate solution intake on thermoregulation2013https://doi.org/10.12659/msm.883991
N.B. These documents automatically identified may not have been verified by the study sponsor.