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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Procedure: warmed with electric blankets; Other: patients without warming

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Diyarbakır, Turkey, 21070
    • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: warmed with electric blankets; warmed with electric blankets
Other: 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	Other: patients without warming; patients without warming: no electric blanket will be used, and no heating will be applied to this group of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."	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	The evaluation will be made according to this rating: Grade 1: no tremor Grade 2: mild tremor with mild facial and cervical muscle contraction Grade 3: moderate tremor with obvious tremor of the head and neck, shoulders and/or extremities Grade 4: severe tremor consisting of an obvious tremor all over the body	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	micrograms of fentanyl consumed	during surgery]
Average blood pressure	Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.	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	the measurement will be obtained by electrocardiographic monitoring	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.
nausea-vomiting	-Postoperative nausea and vomiting will be assessed using a 100 mm VAS: 1- severe nausea (VAS>70 mm), 2- moderate nausea (50<VAS<70 mm), 3- mild nausea (VAS <50 mm).	The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Investigators: Study Director: Cem K. Kaçar, Assoc.Prof, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): August 19, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 11.25.2022/235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No