Clinical trial NCT04741815: Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery
Official title: The Effect of Different Warming Methods Applied to Patients for Prevention of Hypothermia on Pain, Comfort and Some Parameters in Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadvertent Perioperative Hypothermia
Keywords: Inadvertent Perioperative Hypothermia
laparoscopic cholecystectomy
nurse
pain
physiological parameters
shivering
thermal comfort
Lead sponsor: Bozok University
Sponsor class: OTHER
Collaborators: name: Ataturk University
First posted: 2021-02-05
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. However, even surgery alone is an 80% important cause of hypothermia. Inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. In most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. Despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. In the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.

Detailed description: The parallel group randomized controlled three group study blinded by the evaluator aims to investigate the effectiveness of different warming methods in laparoscopic cholecystectomy patients. This study general surgery at Yozgat Bozok University Hospital in Turkey are performed in clinics. All patients are male and female patients who have undergone surgery and met the inclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Patients are qualified to answer research questions,
* BMI is between 18.5 kg / m2 and 30 kg / m2,
* Not using therapeutic hypothermia in the surgery,
* Not being treated with chronic opioids,
* Operation time is between 60 minutes and 6 hours,
* Having received general anesthesia during the operation,
* Reception of patients with ASA classification I or II,
* Absence of anemia, coagulation problem and peripheral circulatory disease or metabolic disease.

Exclusion Criteria:

* Intraoperative and postoperative have complications (bleeding, arrest, nausea, vomiting, etc.),
* Conversion of surgery from laparoscopy to open surgery.

Primary outcomes:
measure: Pain Visual Analog Scale
timeFrame: It is measured preoperatively and after the end of the operation at the 30th minute, 12th hour and 24th hour (up to 24 hours). Change from baseline Pain Visual Analog Scale scores at 24 hours.
measure: Thermal Comfort Visual Analog Scale
timeFrame: It is measured before surgery and every half hour after surgery (up to 2 hours). The change in thermal comfort score before and within the first two hours after surgery is recorded.
measure: Body Temperature Scale
timeFrame: It is measured before surgery and every fifteen minutes after surgery (up to 2 hours). The change in Body Temperature Scale score before and within the first two hours after surgery is recorded.
Secondary outcomes:
measure: Tremor Rating Scale
timeFrame: It is measured before and every 15 minutes after surgery (up to 1 hour). Changes in tremor from the first minute to an hour after surgery.
measure: Hemoglobin Parameters Scale
timeFrame: The hemoglobin level is measured before surgery and at 24th hours after surgery (up to 24 hours). Change from baseline hemoglobin level scores at 24 hours.
measure: International Normalized Ratio Parameters Scale
timeFrame: The Pt INR level is measured before surgery and at 1th hours after surgery (up to 1 hours). Change from preoperative Pt INR level at postoperative 1st hour.
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University Health Sciences Faculty
Study officials:
References: