Laparoscopy
Conditions
Keywords
music, inflammation
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.
Interventions
OTHERmusic
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.
OTHERNo music
Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.
PROCEDURELaparoscopic Surgery
Patients will undergo Laparoscopic Surgery as per the set protocol
Sponsors
Sir Ganga Ram Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin 6 (IL-6) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tumor necrosis factor -α (TNF-α) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | serum levels of TNF-α will be measured preoperatively and postoperatively at 6 hours and 24 hours postoperatively to compare the inflammatory stress response to surgery |
| Change in CD-3+ (T cells) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
| Change in CD-3+/CD-4+ ratio | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
| Change in Highly sensitive C-reactive protein (HS-CRP) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
| Change in CD-19 (B cells) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
| Change in Natural Killer Cells-(NK-Cells) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
| Change in Immature platelet factor (IPF) | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
| Change in CD-3+/CD-8+ ratio | Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively | 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 |
Countries
India
Contacts
Primary ContactBrij Bhushan Agarwal, MS
Backup ContactNeeraj Dhamija, DNB
Outcome results
None listed