跳至主要内容
临床试验/CTRI/2024/11/077395
CTRI/2024/11/077395尚未招募4 期

Effect of short-term yoga on myocardial protection in patients undergoing off-pump coronary artery bypass surgery: A randomized controlled study

Dr Anuraag Kumar Kashyap1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月9日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To study the effect of short-term yoga on myocardial protection in patients undergoing OPCAB surgery as assessed by Troponin I and pro-BNP levels to be assessed 6,24,48,72 hours postoperatively

研究概览

简要总结

Preoperative: Yoga sessions will be held for the patients during their hospitalization in the cardiothoracic and vascular surgery (CTVS) ward in the evening in a dedicated yoga room for a total duration of 60 min per session for five days before surgery. The yoga instructor will brief the patients about the yoga sessions and supervise the performance of the following asanas by the patients: chest exercises with breathing(10mins), anulom-vilom pranayama (10 min), udgith pranayama (10 min), nadi shodhana pranayama (5 min), sheetali pranayama (5 min), bhramari pranayama (5 min), and yog nidra/relaxation (15 min).Patients in the control group will be taken to the yoga room without a yoga intervention. Five sessions will be conducted over five days. The patient’s baseline pro-BNP and troponin I levels will be evaluated preoperatively before the start of the first session. The HADS will be used to calculate anxiety scores among the patients. It comprises seven questions for depression and seven questions for anxiety.

Inraoperatively- The SPI values range from 0 to 100, and higher values indicate a greater nociceptive (stress) response. The target range for adequate intraoperative analgesia during general anesthesia is usually 20–50. An increase in SPI > 50 will be regarded as an indicator of intraoperative pain. It will be managed with a bolus dose of 1 μg/kg of fentanyl.The vasoactive inotropic score (VIS) score will also be calculated for all the patients across both groups.

Postoperative: The proBNP, Trop I levels, and VIS score will be again measured after 6,24,48,72 hours of surgery. The anxiety score will also be calculated post-surgery after the patient has extubated and breathes spontaneously.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing OPCAB surgery.
  • Adult patients between 18-70 years of either gender.
  • Patients having LVEF more than 50 percent.

排除标准

  • Patient’s refusal of consent.
  • Patients already practicing yoga.
  • Patients having orthopaedic impediments to yoga.
  • Intraoperative conversion to on-pump CABG surgery.

结局指标

主要结局

To study the effect of short-term yoga on myocardial protection in patients undergoing OPCAB surgery as assessed by Troponin I and pro-BNP levels to be assessed 6,24,48,72 hours postoperatively

时间窗: To study the effect of short-term yoga on myocardial protection in patients undergoing OPCAB surgery as assessed by Troponin I and pro-BNP levels to be assessed 6,24,48,72 hours postoperatively

次要结局

  • . To study the effect of short-term yoga on perioperative anxiety & depression in patients undergoing OPCAB surgery as assessed by the hospital anxiety & depression scale (HADS).
  • To study the effect of short-term yoga on intraoperative opioid consumption in patients undergoing OPCAB surgery as assessed by the surgical plethysmography index (SPI).

研究者

发起方
Dr Anuraag Kumar Kashyap
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anuraag Kumar Kashyap

All India Institute Of Medical Sciences Bathinda

研究点 (1)

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