Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166186
• Other study ID #: anestezi3
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: February 2024

Study information

• Verified date: October 2023
• Source: Istinye University
• Contact: Taylan Sahin, M.D.
• Phone: +905452303111
• Email: taylansah[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatectomy
• Music
• Stress Response
• Transplantation

Intervention

Other:
• music
A music with a standard volume will be delivered to the patients via headphones from the beginning of anesthesia induction to extubation.
• no music
Headphones will be applied to the patients but no music will be played from the beginning of anesthesia induction to extubation.

Locations

Country	Name	City	State
Turkey	Istinye University Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istinye University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Interleukin-6 (IL-6)	Serum levels of IL-6 will be measured preoperatively and postoperatively.	4 hours
Secondary	Difference in tumor necrosis factor alpha (TNF-alfa)	Serum levels of TNF-alpha will be measured preoperatively and postoperatively.	4 hours
Secondary	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
Secondary	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
Secondary	Difference in c-reactive protein (CRP)	Serum levels of CRP will be measured preoperatively and postoperatively.	24 hours
Secondary	Difference in alanine aminotransferase (ALT)	Serum levels of ALT will be measured preoperatively and postoperatively.	24 hours
Secondary	Difference in aspartate aminotransferase (AST)	Serum levels of AST will be measured preoperatively and postoperatively.	24 hours
Secondary	Difference in creatinine	Serum levels of creatinine will be measured preoperatively and postoperatively.	24 hours
Secondary	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
Secondary	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
Secondary	Differences in pain scores	Assessed 1st, 6th, 12th and 24th hour postoperatively. (from 0 (no pain) to 10 (maximal possible pain))	24 hours