Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

Study Overview
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Brief Summary
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It has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. It has been reported that music can be used as an alternative non-pharmacological method to reduce pain and anxiety in the perioperative period, as well as surgical stress and the related stress response. The aim of this study is to test the hypothesis that music used as a non-pharmacological method in the intraoperative period can reduce inflammatory response in living donor hepatectomy.

Official Title
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Effect of Intraoperative Music on Inflammatory Response in Adult Living Donor Hepatectomy.

Conditions
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Transplantation, Hepatectomy, Music, Stress Response

Intervention / Treatment
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* Other: music
* Other: no music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing donor hepatectomy American Society of Anesthesiologists class 1 to 2 Ability to consent Exclusion Criteria: American Society of Anesthesiologists greater than 2 Documented or known sensitivity to any drug to be used in the study. Patient with immunosuppressant/ cytotoxic/ steroid therapy. not understand the aim and objectives of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music Group<br>Music will be delivered via headphones intraoperatively. Blood samples will be collected as per the protocol. | Other: music<br>* A music with a standard volume will be delivered to the patients via headphones from the beginning of anesthesia induction to extubation.<br>|
| Active Comparator: Control Group<br>Headphones will be applied but no music will be played intraoperatively. Blood samples will be collected as per the protocol. | Other: no music<br>* Headphones will be applied to the patients but no music will be played from the beginning of anesthesia induction to extubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Interleukin-6 (IL-6) | Serum levels of IL-6 will be measured preoperatively and postoperatively. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in tumor necrosis factor alpha (TNF-alfa) | Serum levels of TNF-alpha will be measured preoperatively and postoperatively. | 4 hours | 
| Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period. | Blood samples will be collected preoperatively and postoperatively to measure serum levels of TAC. Blood samples will be stored in medical refrigerator and analysis for serum levels of TAC will be done after collection of all samples. | 4 hours | 
| Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period. | Blood samples will be collected preoperatively and postoperatively to measure serum levels of TOC. Blood samples will be stored in medical refrigerator and analysis for serum levels of TOC will be done after collection of all samples. | 4 hours | 
| Difference in c-reactive protein (CRP) | Serum levels of CRP will be measured preoperatively and postoperatively. | 24 hours | 
| Difference in alanine aminotransferase (ALT) | Serum levels of ALT will be measured preoperatively and postoperatively. | 24 hours | 
| Difference in aspartate aminotransferase (AST) | Serum levels of AST will be measured preoperatively and postoperatively. | 24 hours | 
| Difference in creatinine | Serum levels of creatinine will be measured preoperatively and postoperatively. | 24 hours | 
| Differences in preoperative State-Trait Anxiety Inventory scores | assessed 1 day before surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety. | 20 minutes | 
| Differences in postoperative State-Trait Anxiety Inventory scores | assessed 1st day after surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety. | 20 minutes | 
| Differences in pain scores | Assessed 1st, 6th, 12th and 24th hour postoperatively. (from 0 (no pain) to 10 (maximal possible pain)) | 24 hours |