An interventional study of pranayama yoga and control group in Anesthesia and Closed Loop Anesthesia Delivery System (CLADS), sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-09-05.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Supportive care
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:
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:
Yoga sessions will be held for the patients during their hospitalization in the CTVS ward in the evening in a dedicated YOGA room. A YOGA instructor will train the patients for the YOGA sessions. Target is to give a minimum of 5 sessions of YOGA in this group of patient. yoga training will be done for 60 min. The vital signs (HR, BP, and SPO2)of the patients before and after each session will be recorded using multi-parameter vital sign monitors.
Anulom Vilom Pranayam: (10 min)
The patient will be asked to sit comfortably and close his eyes.
Open the left nostril, breathe out slowly. Udgith Pranayama (10 min )
Nadishodhana Pranayama (10 minutes)
Sheetali (5 min) The patients will be made to sit in a comfortable posture with spine erect and in line with neck and head.Eyes will be closed gently.
Bhramari Pranayama ( 10 min )
YogNidra / Relaxation (15 min)
The participant will be made to lie down in Shavasana and made to follow the instructions.
Group C;
Patients in this group will not be given any yoga session and will thus act as a control group. The vital signs (HR, BP, and SPO2)of the patients will be recorded using multi-parameter vital sign monitors for the subsequent days after recruitment and group allocation.
Anesthetic management for cardiac surgery:
Anxiety score will be measured by using the State-Trait Anxiety Inventory (STAI) on the day of surgery. The hemodynamic parameters will be recorded for subsequent comparison of the effect of Yoga.
This will be followed by insertion of a 16 G i.v cannula after giving local anesthetic with a 26 G needle. Following monitors will be attached: continuous pulse oximetry (SpO2), electrocardiogram (ECG), periodic non-invasive blood pressure (S/Anesthesia monitor, Datex Ohmeda Inc., Madison, WI), and continuous BIS (BIS XP, Aspect Medical Systems, Newton, MA in the S/5 Anesthesia monitor). Pre-induction arterial line and the central line will be secured in all patients after giving local anesthetic and continuous arterial blood pressure and central venous pressure measurements will be recorded.
Induction of anesthesia will be performed with propofol using closed-loop anesthesia delivery system (CLADS) titrated to target BIS of 50 and fentanyl 3 mcg/kg in both groups. Muscular paralysis for tracheal intubation will be achieved by vecuronium bromide 0.1mg/kg followed by intermittent boluses. After intubation, volume-controlled mechanical ventilation to be provided with FiO2 0.5, tidal volume 7-8 ml/kg, positive end-expiratory pressure (PEEP) 5 cm H2O, and respiratory rate of 12-14/min. Patients will be mechanically ventilated with air: oxygen mixture (50:50) to maintain end-tidal carbon dioxide (ETCO2) values between 30 and 35 mm Hg. Maintenance of anesthesia will be done with propofol infusion using CLADS titrated to target BIS value of 40-60. Fentanyl infusion at 1.0 mcg/kg/h will be administered for analgesia. Fentanyl 1 mcg/kg will be administered before sternotomy. Nasopharyngeal temperature, urinary output, and ETCO2 will be recorded. CPB will be initiated after heparinization with an intravenous dose of 3 mg/kg titrated to the ACT of 450 seconds.Every 20 min, cardioplegia will be repeated. The MAP will be maintained in the range 50-70 mm Hg during CPB. Weaning from CPB will be performed in a stepwise manner. Appropriate inotropes adrenaline/ noradrenaline/ dopamine/ milrinone will be used to maintain adequate tissue perfusion and cardiac output. Fluid replacement will include crystalloid solutions with an initial infusion rate 6-7 ml.kg.hr prior to and during anesthesia and 2- 3 ml/kg/hr postoperatively. All the anesthesia drug consumption data will be recorded online using CLADS.
Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
yoga breathing exercise
Behavioral: pranayama yoga
no intervention
Other: control group
providing short term pranayama yoga for 5 sessions before surgery patients under going cardiac surgery.
Also known as: yoga breathing exerxises
no intervention should be given to patients allocated to this group
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.
Heart rate will be measured before and after every yoga session for 5 consecutive days
Time frame: minimum 5 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.
Mean arterial pressure will be measured before and after every yoga session for 5 consecutive days
Time frame: Minimum 5 days
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.
SpO2 will be measured before and after every yoga session for 5 consecutive days
Time frame: Minimum 5 days
the effect of YOGA on pre operative anxiety. pre operative anxiety will be measured by STAI (state and trait anxiety inventory) scale
pre operative anxiety will be measured by STAI scale before first yoga session and after last yoga session
Time frame: minimum 5 days preoperatively
consumption of propofol
intra operative consumption of opioid propofol consumption during induction and maintenance of anesthesia
Time frame: approx 8-12hrs
Fentanyl consumption
intra operative consumption of opioid fentanyl consumption during induction and maintenance of anesthesia
Time frame: approx 8-12 hrs
vecuronium consumption
intra operative consumption of muscle relaxant vecuronium during induction and maintenance of anesthesia
Time frame: approx 8-12 hrs
post-operative anxiety. Post operative anxiety will be measured by STAI (state and trait anxiety inventory) scale
will be measured by using STAI score 12 hours after extubation
Time frame: at 12 hrs after extubation
post-operative outcome (complications)
post operative complications related to surgery and anesthesia
Time frame: approx 7 days
Plan to share: No
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Post Graduate Institute of Medical Education and Research, Chandigarh