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临床试验/NCT02827292
NCT02827292Unknown不适用

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

Sir Ganga Ram Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change in Interleukin 6 (IL-6)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 18 years.
  • Should be able to understand and sign an informed consent.
  • Consent to the use of standard music during surgery.
  • Ability to maintain & communicate a PRO diary.
  • Ability to communicate via telephone or email or text message (SMS).
  • Fitness for general anaesthesia (ASA grade-I and ASA grade-II)

排除标准

  • Surgery for incidental Gall Bladder (GB) disease in patients for other surgeries.
  • Concomitant common bile duct (CBD) stone or any CBD intervention/pancreatitis in the preceding 6 weeks.
  • Non acceptance for the standard music or objection to any unknown music.
  • Suspicion of carcinoma gallbladder on ultrasonography
  • Patients with neuropathic pain/chronic pain needing regular anti-inflammatory drugs.
  • Documented or known sensitivity to any drug to be used in the study protocol.
  • Patient on immunosuppressant/ cytotoxic/ steroid therapy.
  • Pregnant or lactating ladies.

研究组 & 干预措施

Laparoscopic Surgery without music

Experimental

Intervention: Headphones without music (Silent). A headphone will be applied peroperatively but no music will be played. Blood samples to assess the biomolecular inflammatory response and the post operative monitoring will be done as per the protocol.

干预措施: No music (Other)

Laparoscopic Surgery without music

Experimental

Intervention: Headphones without music (Silent). A headphone will be applied peroperatively but no music will be played. Blood samples to assess the biomolecular inflammatory response and the post operative monitoring will be done as per the protocol.

干预措施: Laparoscopic Surgery (Procedure)

Laparoscopic Surgery with music

Experimental

Intervention: peroperative music via head phones. A headphone will be applied peroperatively and music will be played for the entire duration of the surgical procedure. Blood samples to assess the biomolecular inflammatory response and the post operative monitoring will be done as per the protocol.

干预措施: music (Other)

Laparoscopic Surgery with music

Experimental

Intervention: peroperative music via head phones. A headphone will be applied peroperatively and music will be played for the entire duration of the surgical procedure. Blood samples to assess the biomolecular inflammatory response and the post operative monitoring will be done as per the protocol.

干预措施: Laparoscopic Surgery (Procedure)

结局指标

主要结局

Change in Interleukin 6 (IL-6)

时间窗: 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

次要结局

  • Change in Highly sensitive C-reactive protein (HS-CRP)(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in Tumor necrosis factor -α (TNF-α)(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in CD-3+ (T cells)(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in CD-3+/CD-4+ ratio(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in CD-3+/CD-8+ ratio(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in CD-19 (B cells)(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in Natural Killer Cells-(NK-Cells)(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)
  • Change in Immature platelet factor (IPF)(Baseline (preoperatively), 6hours postoperatively, 24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

PROF. BRIJ B AGARWAL

Vice Chairman, Department of Laparoscopic and General Surgery

Sir Ganga Ram Hospital

研究点 (2)

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