Effect of Music on Inflammatory Response During Laparoscopic Surgery

Laparoscopy Clinical Trial

Official title:

Effects of Peroperative Music on the Biomolecular Inflammatory Response In Laparoscopic Surgery: A Triple Blind Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02827292
• Other study ID #: SirGangaRamH
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2016
• Last updated: January 17, 2018
• Start date: October 31, 2017
• Est. completion date: October 2018

Study information

• Verified date: January 2018
• Source: Sir Ganga Ram Hospital
• Contact: Brij Bhushan Agarwal, MS
• Phone: +91-9810124256
• Email: endosurgeon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of per-operative music on the bio-molecular inflammatory response in laparoscopic surgery. Per-operative music intervention will be given to the test group via headphones while the control group will be applied headphones without any music (Silent). The inflammatory stress response will be measured postoperatively at 6 hours and 24 hours postoperatively along with the baseline levels measured preoperatively. The values will be compared between the test and control groups.

Description:

Laparoscopic surgery (LS) has gained popularity both amongst surgeon as well as patients. The appeal of LS is based on improved patient reported outcomes (PRO). The main PROs like post operative pain, hospital stay and ability to return to activity are better with LS. The improvement in PROs has been attributed to attenuated post operative inflammatory response. The post operative inflammatory response has been studied by the changes in various cytokine pathways. The cytokine response has been shown to be subdued after LS as compare to conventional surgery. This benefit of subdued cytokine response has been shown to translate into better PROs.

Laparoscopic cholecystectomy (LC) has been considered an index LS. It is also an index LS for evaluation of potentially beneficial intervention in LS. The surgical discourse in last two decades has been to achieve clinical equivalence of LS with conventional surgery. The clinical outcomes with LC have stabilized. The current scientific discourse is geared towards improving PROs. A multi dimensional approach including pre-operative optimisation, protocoled anaesthesia technique, and 'systems approach' based surgery and standardised dissection techniques have been recommended.

Peri-operative music has been shown to improve PROs in LC . A recently published meta-analysis has established the benefits of peri-operative music in post operative convalescence. Peri-operative music has been shown to affect the neurohumoral and cyto-immune expressions of various 'cluster of differentiation' (CD) markers, on various cell lines.

Despite the established efficacy of music, there is reluctance amongst surgeon to adopt it routinely. There is no clarity and scientific curiosity about the type of music and the timing of music intervention, for the observed benefits of peri-operative music. The biomolecular basis of the reported benefits, of music in surgical setting has not been studied in an objective manner.

With this background the investigators hypothesized that per-operative music should have measurable bio-molecular footprint in postoperative convalescence use. With this hypothesis the investigators wish to study the per-operative music effects on the PROs, in laparoscopic cholecystectomy with measurable bio-molecular or/and bio-cellular markers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age more than 18 years.

2. Should be able to understand and sign an informed consent.

3. Consent to the use of standard music during surgery.

4. Ability to maintain & communicate a PRO diary.

5. Ability to communicate via telephone or email or text message (SMS).

6. Fitness for general anaesthesia (ASA grade-I and ASA grade-II)

Exclusion Criteria:

1. Surgery for incidental Gall Bladder (GB) disease in patients for other surgeries.

2. Concomitant common bile duct (CBD) stone or any CBD intervention/pancreatitis in the preceding 6 weeks.

3. Non acceptance for the standard music or objection to any unknown music.

4. Suspicion of carcinoma gallbladder on ultrasonography

5. Patients with neuropathic pain/chronic pain needing regular anti-inflammatory drugs.

6. Documented or known sensitivity to any drug to be used in the study protocol.

7. Patient on immunosuppressant/ cytotoxic/ steroid therapy.

8. Pregnant or lactating ladies.

Related Conditions & MeSH terms

• Laparoscopy

Intervention

Other:
• music
A standard music with a standard volume as per the protocol will be played with headphones during the entire duration of the surgery starting from the point of induction to the time of extubation. A proper silent operative room environment will be maintained.
• No music
Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.

Procedure:
• Laparoscopic Surgery
Patients will undergo Laparoscopic Surgery as per the set protocol

Locations

Country	Name	City	State
India	Prof. Brij Bushan Agarwal	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Sir Ganga Ram Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Interleukin 6 (IL-6)	serum levels of IL-6 will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in Highly sensitive C-reactive protein (HS-CRP)	serum levels of HS-CRP will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in Tumor necrosis factor -a (TNF-a)	serum levels of TNF-a will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in CD-3+ (T cells)	serum levels of CD-3+ (T cells) will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in CD-3+/CD-4+ ratio	serum levels of CD-3+/CD-4+ ratio will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in CD-3+/CD-8+ ratio	serum levels of CD-3+/CD-8+ ratio will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in CD-19 (B cells)	serum levels of CD-19 (B cells) will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in Natural Killer Cells-(NK-Cells)	serum levels of NK-Cells will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary	Change in Immature platelet factor (IPF)	serum levels of IPF will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery	Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively