| 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
|
|
|
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
|
|
|
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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