NCT06022926

Investigation of the Intraoperative and Postoperative Effects of Warming Patients in Laparoscopic Cholecystectomy

Effects of Patient Warming With Electric Blanket on Intraoperative Hemodynamics; Postoperative Nausea, Vomiting, Chills, Agitation and Pain in Laparoscopic Cholecystectomy Operation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Days – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
PROCEDURE	warmed with electric blankets	warmed with electric blankets
OTHER	patients without warming	patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-08-19
• Completion: 2024-08-20
• First posted: 2023-09-05
• Last updated: 2024-08-21

Locations

1 site across 1 country: Turkey (Türkiye)