Clinical trial NCT06022926: Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy
Official title: Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Laparoscopic cholecystectomy operation will be
* To be between 18-65 years old.
* Being American Society of Anesthesiologists (ASA) Classification I-II.

Exclusion Criteria:

* Preoperative body temperature \>37.5°C or \<36°C.
* Impaired temperature regulation such as systemic infection, mental retardation, isolated head trauma or brain injury.
* Receiving a medication that affects thermoregulation.
* Being American Society of Anesthesiologists (ASA) Classification \>III.

Primary outcomes:
measure: Agitation assessment
timeFrame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
Secondary outcomes:
measure: Pain assessment
timeFrame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
measure: post-operative tremor
timeFrame: Within 30 minutes from the time the patient was extubated to the time of extubation from the postoperative recovery unit to the ward.
measure: Amount of fentanyl consumed intraoperatively
timeFrame: during surgery]
measure: Average blood pressure
timeFrame: 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.
measure: Heart rate
timeFrame: 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.
measure: nausea-vomiting
timeFrame: The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
name: Cem K. Kaçar, Assoc.Prof
role: STUDY_DIRECTOR
References:
citation: 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.