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

S

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Status

Completed

Conditions

Laparoscopic Cholecystectomy

Treatments

Other: patients without warming
Procedure: warmed with electric blankets

Study type

Interventional

Funder types

Other

Identifiers

NCT06022926
11.25.2022/235

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 patients

Sex

All

Ages

18 days to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

128 participants in 2 patient groups

Group 1: Patients warmed with electric blankets
Active Comparator group
Description:
* 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
Treatment:
Procedure: warmed with electric blankets
Group 2: Control group (patients without warming)
Other group
Description:
* 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
Treatment:
Other: patients without warming

Trial contacts and locations

1

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Central trial contact

Fatma Acil, M.D.

Data sourced from clinicaltrials.gov

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