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临床试验/NCT03127891
NCT03127891已完成不适用

Effect of Short Term Pranayama on Anaesthesia Management in Patients Undergoing Cardiac Surgery

Post Graduate Institute of Medical Education and Research, Chandigarh2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
The effect of pre-operative short term pranayama yoga on SpO2 in patients scheduled for cardiac surgery. Measuring SpO2 using clarity ARGUS LCM PLUS multi - parameter monitor.

研究概览

简要总结

TITLE: EFFECT OF SHORT-TERM PRANAYAMA ON ANAESTHESIA MANAGEMENT IN PATIENTS UNDERGOING CARDIAC SURGERY

Primary aim: To evaluate the effect of pre-operative short term pranayama yoga on stress-induced hemodynamic (HR, MAP) changes in patients scheduled for cardiac surgery.

Secondary aims:

  1. To compare the effect of YOGA on preoperative anxiety.
  2. To compare the effect of Yoga on SPO2.
  3. To compare effect of Yoga on total consumption of propofol administered using Closed Loop Anaesthesia Delivery system(CLADS)
  4. To compare effect of Yoga on total consumption of fentanyl, and vecuronium
  5. To compare effect of Yoga on post-operative anxiety (after extubation in CTVS ward)
  6. To compare effect of Yoga on postoperative outcome in terms of duration of mechanical ventilation, duration of ICU stay, incidence of complications and post-op mortality

详细描述

TITLE: EFFECT OF SHORT-TERM PRANAYAMA ON ANESTHESIA MANAGEMENT IN PATIENTS UNDERGOING CARDIAC SURGERY

This will be a prospective randomized controlled pilot study. After Institutional Ethics Committee approval and written informed consent patients aged 20-60 years and scheduled for elective cardiac surgery will be assessed for eligibility.

All patients admitted in the CT VS ward and awaiting elective surgery in the next 5-6 days will be recruited. The patients will be divided randomly into two groups using random number table; Group C: Control, Group Y: Yoga. Allocation will be done using sealed envelope technique. The study will be conducted from October 2016 to December 2017.

Before any intervention the baseline haemodynamic parameters will be recorded and general anxiety score will be measured using Spielberg's state-trait anxiety inventory (STAI).

Group Y:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 20-60y
  • Cardiac surgery( valvular heart disease and coronary artery disease)

排除标准

  • Severe restrictive lung disease
  • Severe obstructive lung disease
  • Drug addicts
  • History of smoking
  • Alcohol intake
  • Central nervous system disease
  • Psychiatric disorder

研究组 & 干预措施

control group

Placebo Comparator

no intervention

干预措施: control group (Other)

pranayama yoga

Experimental

yoga breathing exercise

干预措施: pranayama yoga (Behavioral)

结局指标

主要结局

The effect of pre-operative short term pranayama yoga on SpO2 in patients scheduled for cardiac surgery. Measuring SpO2 using clarity ARGUS LCM PLUS multi - parameter monitor.

时间窗: Minimum 5 days

SpO2 will be measured before and after every yoga session for 5 consecutive days

The effect of pre-operative short term pranayama yoga on heart rate in patients scheduled for cardiac surgery. Measuring heart rate by using clarity ARGUS LCM PLUS multi - parameter monitor.

时间窗: minimum 5 days

Heart rate will be measured before and after every yoga session for 5 consecutive days

The effect of pre-operative short term pranayama yoga on mean arterial pressure in patients scheduled for cardiac surgery. Measuring mean arterial pressure using clarity ARGUS LCM PLUS multi - parameter monitor.

时间窗: Minimum 5 days

Mean arterial pressure will be measured before and after every yoga session for 5 consecutive days

次要结局

  • the effect of YOGA on pre operative anxiety. pre operative anxiety will be measured by STAI (state and trait anxiety inventory) scale(minimum 5 days preoperatively)
  • Fentanyl consumption(approx 8-12 hrs)
  • vecuronium consumption(approx 8-12 hrs)
  • consumption of propofol(approx 8-12hrs)
  • post-operative anxiety. Post operative anxiety will be measured by STAI (state and trait anxiety inventory) scale(at 12 hrs after extubation)
  • post-operative outcome (complications)(approx 7 days)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

aspari mahammad azeez

Junior resident, dept.of anesthesia and intensive care

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (2)

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