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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anesthesia

thermoregulation

preoperative diet

Condition category

Condition code

Anaesthesiology

Anaesthetics

Diet and Nutrition

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]

Prevention

Intervention code [2]

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]

tympanic temperature
(for tympanic membrane injury was prevented, tympanic temperature measured via infrared thermometer)

Timepoint [1]

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]

mean skin temperature [0.3 (Tchest+Tarm) + 0.2 (Tthigh+Tcalf)]
(peripheral temperatures measured via anesthesia machine thermometers)

Timepoint [2]

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]

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Ayse Belin OZER

Address

Department of Anesthesiology and Reanimation, Firat University, 23119, Elazig

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Firat University Medical School Ethical Evaluation Commission Chairman

Ethics committee address [1]

Firat University Medical School Ethical Evaluation Commission Chairman 
Firat University
23119,Elazig

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

07/02/2011

Approval date [1]

10/03/2011

Ethics approval number [1]

Summary

Brief summary

Background: Anesthesia practices is among practices that change heat regulation system and thus make patients lead to hypothermia. The aim of this study is to investigate the oral carbohydrate solution administered preoperatively on heat regulation system.  
Methods: The study included 40 female patients that were implemented general anesthesia. Patients were randomly divided into two groups: Group C (patients that stopped oral implementation 8 hours before the operation) and Group CH (800 ml oral carbohydrate fluid 8 hours before the operation and 400 ml oral carbohydrate fluid 2 hours before the operation). Patients were monitored as standard and temperature probes were placed. Heart rate, mean arterial pressure, and central and peripheral temperatures were recorded immediately before anesthetics induction, 5 minute intervals after the anesthetics induction, and in PACU every 10 minutes. Mean skin temperature, mean body temperature, and vasoconstriction threshold were estimated with the help of recorded temperatures.
Results: A statistically significant difference was not observed between demographic data of patients. In general, a decrease in tympanic and mean body temperature following anesthetic administration in groups, and increase in mean skin temperature, and an increase were observed in all these three levels in recovery unit. Tympanic temperature was found to be significantly high at 25th, 55th, 65th, and 95th minutes before and after induction in Group C compared to Group CH. (p<0.05). Although mean skin temperature was found to be lower in Group C compared to Group CH in almost all periods, it was established that it did not have any significant difference in mean body temperature. In PACU, it was found that the tympanic temperature was higher in Group C compared to Group CH at the 60th minute (p<0.05). Postoperative shivering score was found to be significantly higher in Group C compared to Group CH (p<0.01). Vasoconstriction occurred at the 50th minute in Group C and 75th minute in Group CH. Vasoconstriction threshold was established to be 35.45 plus/minus 0.72 C degrees in Group C and 34.77 plus/minus 0.53 C degrees in Group CH. 
Conclusions: Oral carbohydrate solution administered in preoperative period was established to have effects (as decrease in tympanic temperature and vasoconstriction threshold) thought to be negative on tympanic temperature, vasoconstriction, and vasoconstriction threshold and to significantly decrease however the postoperative tremor.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Ayse Belin OZER

Address

Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119, Elazig

Country

Turkey

Phone

+90 424 533 4478924

Fax

+90 424 2388096

abelinozer@gmail.com

Contact person for scientific queries

Name

Ayse Belin OZER

Address

Firat University Medicine Faculty
Anesthesiology and Reanimation Department
23119, Elazig

Country

Turkey

Phone

+90 424 533 4478924

Fax

+90 424 2388096

abelinozer@gmail.com

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

Source	Title	Year of Publication	DOI
Dimensions AI	Effects of preoperative oral carbohydrate solution intake on thermoregulation	2013	https://doi.org/10.12659/msm.883991

N.B. These documents automatically identified may not have been verified by the study sponsor.

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