In our study, the investigators will investigate the effects of electric blanket heating on intraoperative hemodynamics, postoperative nausea, vomiting, shivering, agitation and pain in patients undergoing laparoscopic cholecystectomy under general anesthesia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
128
warmed with electric blankets
patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey (Türkiye)
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.
Time frame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
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."
Time frame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
post-operative tremor
The evaluation will be made according to this rating: Grade 1: no tremor Grade 2: mild tremor with mild facial and cervical muscle contraction Grade 3: moderate tremor with obvious tremor of the head and neck, shoulders and/or extremities Grade 4: severe tremor consisting of an obvious tremor all over the body
Time frame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
Amount of fentanyl consumed intraoperatively
micrograms of fentanyl consumed
Time frame: during surgery]
Average blood pressure
Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
Time frame: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
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Heart rate
the measurement will be obtained by electrocardiographic monitoring
Time frame: Assessments will be performed at 0 minutes immediately before induction of anesthesia, 20 minutes after induction, immediately after extubation and 20 minutes in the recovery unit after anesthesia.
nausea-vomiting
-Postoperative nausea and vomiting will be assessed using a 100 mm VAS: 1- severe nausea (VAS\>70 mm), 2- moderate nausea (50\<VAS\<70 mm), 3- mild nausea (VAS \<50 mm).
Time frame: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.