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

NCT06022926 | Completed

• 1 other identifier: 11.25.2022/235
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Will be assessed from immediately after extubation until transfer from the recovery room to the ward.

Secondary Outcomes (6)

• Pain assessment

  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

  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

  during surgery]

• Average blood pressure

  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.

• Heart rate

  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.

Study Arms (2)

Group 1: Patients warmed with electric blankets

ACTIVE COMPARATOR

* 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

Procedure: warmed with electric blankets

Group 2: Control group (patients without warming)

OTHER

* 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

Other: patients without warming

Interventions

warmed with electric blankets PROCEDURE

warmed with electric blankets

Group 1: Patients warmed with electric blankets

patients without warming OTHER

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

Group 2: Control group (patients without warming)

Eligibility Criteria

• Age: 18 Days - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23691884 BACKGROUND

• Dedeoglu A, Acil F, Andic O, Ozkilic M. Effect of Intraoperative Active Warming Initiated at Anesthesia Induction on Core Temperature, Postoperative Pain and Agitation in Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2026 Jan 15;62(1):175. doi: 10.3390/medicina62010175.

  PMID: 41597461 DERIVED

Study Officials

• Cem K. Kaçar, Assoc.Prof

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Spesialist

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 5, 2023
• Study Start: October 3, 2023
• Primary Completion: August 19, 2024
• Study Completion: August 20, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

TU (1)