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CTRI Number  CTRI/2024/11/077395 [Registered on: 27/11/2024] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Yoga & Naturopathy
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effect of short-term yoga intervention on the outcome of myocardial protection in patients undergoing off-pump coronary artery bypass surgery 
Scientific Title of Study   Effect of short-term yoga on myocardial protection in patients undergoing off-pump coronary artery bypass surgery: A randomized controlled study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuraag Kumar Kashyap 
Designation  post graduate resident 
Affiliation  All India Institute Of Medical Sciences Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda, Mandi Dabwali Rd, Bathinda, Punjab 151001.

Bathinda
PUNJAB
151001
India 
Phone  8638887438  
Fax    
Email  kashyap.anurag30@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Navneh Samagh 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda, Mandi Dabwali Rd, Bathinda, Punjab 151001.

Bathinda
PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Navneh Samagh 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda, Mandi Dabwali Rd, Bathinda, Punjab 151001.

Bathinda
PUNJAB
151001
India 
Phone  8427264480  
Fax    
Email  navnehsamagh@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda, Punjab, India 151001 
 
Primary Sponsor  
Name  Dr Anuraag Kumar Kashyap 
Address  Department of Anaesthesiology, AIIMS Bathinda, Mandi Dabwali Rd, Bathinda, Punjab 151001 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anuraag Kumar Kashyap  Department of Anaesthesiology, All India Institute of Medical Sciences, Bathinda  Mandi Dabwali Rd, Bathinda, Punjab 151001
Bathinda
PUNJAB 
8638887438

kashyap.anurag30@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No yoga therapy   Patients in Arm 2 will be given no Yoga therapy. Endpoint of study is after 72 hours postoperatively 
Intervention  Short term yoga  Patients in Arm 1 will be given 5 day yoga sessions for 60 mins each session before OPCAB surgery. Endpoint of study is after 72 hours postoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing OPCAB surgery.
Adult patients between 18-70 years of either gender. Patients having LVEF more than 50 percent. 
 
ExclusionCriteria 
Details  1. Patient’s refusal of consent.
2. Patients already practicing yoga.
3. Patients having orthopaedic impediments to yoga.
4. Intraoperative conversion to on-pump CABG surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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
 
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
 
 
Secondary Outcome  
Outcome  TimePoints 
. 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).
 
Five days preoperatively, on the day of surgery, postoperatively 
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).
 
intraoperatively 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.


 
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