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

NCT ID: NCT06022926

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-03
• Study Completion Date: 2024-08-20

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.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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
• 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

Group Type: ACTIVE_COMPARATOR

warmed with electric blankets

Intervention Type: PROCEDURE

warmed with electric blankets

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
• 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

Group Type: OTHER

patients without warming

Intervention Type: OTHER

patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.

Interventions

warmed with electric blankets

warmed with electric blankets

Intervention Type: PROCEDURE

patients without warming

patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Days
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fatma Acil,MD

Anesthesiology and Reanimation Spesialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cem K. Kaçar, Assoc.Prof

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Locations

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 23691884 (View on PubMed)

Other Identifiers

11.25.2022/235

Identifier Type: -

Identifier Source: org_study_id