Clinical trial NCT02827292: Effect of Music on Inflammatory Response During Laparoscopic Surgery
Official title: Effects of Peroperative Music on the Biomolecular Inflammatory Response In Laparoscopic Surgery: A Triple Blind Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopy
Keywords: music
inflammation
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Interleukin 6 (IL-6)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Secondary outcomes:
measure: Change in Highly sensitive C-reactive protein (HS-CRP)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in Tumor necrosis factor -α (TNF-α)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in CD-3+ (T cells)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in CD-3+/CD-4+ ratio
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in CD-3+/CD-8+ ratio
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in CD-19 (B cells)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in Natural Killer Cells-(NK-Cells)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
measure: Change in Immature platelet factor (IPF)
timeFrame: Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively
Other outcomes:
Locations:
city: Delhi
country: India
facility: Prof. Brij Bushan Agarwal
Study officials:
References: