Investigation of the Intraoperative and Postoperative Eff... | NCT06022926

Status Module

Oversight Module

Description Module

Detailed Description

Group 1: Patients warmed with electric blankets

Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour)
all patients will receive standard general anesthesia
all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
the same electric blanket was used for this group of patients
each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table.
heat measurements will be made with the same tympanic heat meter device
heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
Postoperative evaluations of the patients will be performed face to face.
patients will be warmed only during the time they are on the operating table
This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.

Group 2: Control group (patients without warming): no electric blanket will be used, and no heating will be applied to this group of patients.

all patients will receive standard general anesthesia.
all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer.
each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit.
mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit.
temperature measurements will be performed with the same tympanic thermometer device
heat measurements will be made by a blind anesthesiologist with at least 5 years of experience
Postoperative evaluations of the patients will be performed face to face.
This study was followed up in the operating room and post-anesthesia recovery unit in the operating room.

Statistical methods / analysis: G-Power version 3.1.9.4 (University Kiel, Germany) was used to calculate the sample size. Two-tailed alpha error was 0.05, power as 0.80 and effect size as 0.5, and according to a previous study (Comparison of different end-tidal carbon dioxide levels in preventing postoperative nausea and vomiting in gynaecological patients undergoing laparoscopic surgery. Doi: 10.1080/01443615.2020.1789961.) allocation ratio was accepted as N2/N1:1. The minimum number of patients to be included in the study was calculated as 128.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Patients warmed with electric blankets	Active Comparator	Patients will be provided with electric blankets from the beginning to the end of the operation (approximately 1 hour) all patients will receive standard general anesthesia each patient will undergo tympanic temperature measurement immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during exit from the postanesthesia recovery unit. the same electric blanket was used for this group of patients each time the electric blankets were set to 38 degrees and the blankets were preheated to 38 degrees approximately 30 minutes before the patients were placed on the operating table. heat measurements will be made with the same tympanic heat meter device	Procedure: warmed with electric blankets
Group 2: Control group (patients without warming)	Other	no electric blanket will be used, and no heating will be applied to this group of patients. all patients will receive standard general anesthesia all patients will undergo electrocardiogram, peripheral oxygen saturation by pulse oximetry, non-invasive blood pressure monitoring by automatic pneumatic manometer mean arterial pressure, intraoperative opioid consumption, nausea-vomiting, agitation, tremor and pain assessment will be performed on each patient immediately before induction of general anesthesia, 20 minutes after induction of anesthesia, immediately after extubation and during discharge from the postanesthesia recovery unit. temperature measurements will be performed with the same tympanic thermometer device	Other: patients without warming

Name	Type	Description	Arm Group Labels	Other Names
warmed with electric blankets	Procedure	warmed with electric blankets	Group 1: Patients warmed with electric blankets

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Agitation assessment	Agitation assessment with Richmond Agitation Sedation Scale (RASS). The Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm.	Will be assessed from immediately after extubation until transfer from the recovery room to the ward.

Secondary Outcomes

Measure	Description	Time Frame
Pain assessment	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."	Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Cem K. Kaçar, Assoc.Prof	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital		Diyarbakır		21070	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23691884	Background	Tanaka N, Ohno Y, Hori M, Utada M, Ito K, Suzuki T. A randomised controlled trial of the resistive heating blanket versus the convective warming system for preventing hypothermia during major abdominal surgery. J Perioper Pract. 2013 Apr;23(4):82-6. doi: 10.1177/175045891302300404.
41597461	Derived	Dedeoglu A, Acil F, Andic O, Ozkilic M. Effect of Intraoperative Active Warming Initiated at Anesthesia Induction on Core Temperature, Postoperative Pain and Agitation in Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2026 Jan 15;62(1):175. doi: 10.3390/medicina62010175.

IPD Sharing Statement Module