The effect of temperature change during operation of obesity.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000375550
• Date of registration: 23/04/2015
• Prospective Registration: Yes
• Primary sponsor: Ayse Belin OZER
• 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.
• Date of first enrolment: 11/05/2015
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12615000375550.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Turkey

Contacts

• Name: A/Prof Ayse Beklin OZER

• Name: A/Prof Ayse Belin OZER

Key inclusion & exclusion criteria

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.
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.

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Other anaesthesiology

Diet and Nutrition - Obesity

obesity;anesthesia;
obesity
anesthesia

Intervention(s)

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.

Primary Outcome(s)

nasopharengeal temperature
(nasopharengeal temperature measured via anesthesia machine)[before anesthesia induction, in 5-minute intervals after the induction of
anesthesia, and in arrival to PACU]

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)
[before anesthesia induction, in 5-minute intervals after the induction of anesthesia until arrival to PACU]

mean skin temperature [0.3 (Tchest+Tarm) + 0.2 (Tthigh+Tcalf)]
(peripheral temperatures measured via anesthesia machine
thermometers)
[before anesthesia induction, in 5-minute intervals after the induction of anesthesia until arrival to PACU.]

Secondary Outcome(s)

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)
[On admission to post anesthetic care unit]

Secondary ID(s)

nil

Ethics review

Status: Approved
Approval date:
Contact:

Firat University Ethical Evaluation Commission Chairman