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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022926
• Other study ID #: 11.25.2022/235
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: April 2024
• Source: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
• Contact: Fatma Acil, M.D.
• Phone: +905337225225
• Email: acilfatma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: May 20, 2024
• Est. primary completion date: May 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Days to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Amount of fentanyl consumed intraoperatively	micrograms of fentanyl consumed	during surgery]
Secondary	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.
Secondary	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.
Secondary	nausea-vomiting	-Postoperative nausea and vomiting will be assessed using a 100 mm VAS: 1- severe nausea (VAS>70 mm), 2- moderate nausea (50	The evaluation will be performed at postoperative 0th hour, 2nd hour, 6th hour and 24th hour.