Effect of Yoga on Anesthesia Management
Condition: Anesthesia; Closed Loop Anesthesia Delivery System (CLADS)
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.

        -  Close the right nostril with the right thumb

        -  Inhale slowly through the left nostril and fill lungs with air.

        -  Close left nostril with the ring and middle fingers of the right hand and open the right
           nostril.

        -  Exhale slowly and completely with the right nostril.

        -  Again inhale through the right nostril and fill lungs.

        -  Close the right nostril by pressing it with the right thumb.

        -  Open the left nostril, breathe out slowly. Udgith Pranayama (10 min )

             1. The patient will be made to sit in a comfortable posture with spine erect and in
                line with neck and head.

             2. He/She will be instructed to put the hands in Gyan mudra and eyes closed.

             3. Being aware of their breath, the participant will be instructed to breathe deeply
                through the nose.

             4. During exhalation "AUM" will be chanted for as long as their body allows.The
                participant will not be stressed.

      Nadishodhana Pranayama (10 minutes)

        1. The patient will be made to sit in a comfortable posture with spine erect and in line
           with neck and head

        2. The participant will be instructed to fold the index finger and middle finger of the
           right hand in such a way that their tips touch the root of the right thumb. The ring
           finger and little finger of right hand will be extended and placed on the left nostril.
           Right thumb will be placed on right nostril

        3. The participant will be made to close the eyes.

        4. The right nostril will be closed and deep inhalation will be taken from the left
           nostril.

        5. The left nostril will be closed and exhalation will be carried out through the right
           nostril.

        6. Inhalation will be done through right nostril keeping the left nostril closed.

        7. Exhalation will be done through left nostril keeping the right nostril closed.

        8. This will complete one round.

      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.

        1. The patients will be instructed to open their mouth and stretch the tongue as long as
           he/she can.

        2. The tongue will be rolled from sides such that tongue takes the form of a hollow tube.

        3. Air will be inhaled through this hollow tube.

        4. Later, the mouth will be closed and exhalation will be carried out through the nose.

      Bhramari Pranayama ( 10 min )

        1. 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.

        2. The hands will be preferably kept in Shanmukhi mudra. If not comfortable, Gyan mudra
           will have opted and eyes will be kept closed.

        3. Being aware of their breath, the participant will be instructed to breathe deeply
           through nose

        4. During exhalation, humming sound will be produced for as long as the participant's body
           allows. They will not be stressed.

        5. The vibration generated within the body will be felt.

      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.
    

Intervention name(s): pranayama yoga; control group
Intervention type(s): Behavioral; Other
Intervention description(s): providing short term pranayama yoga for 5 sessions before surgery patients under going cardiac surgery.; no intervention should be given to patients allocated to this group
Other intervention name(s): yoga breathing exerxises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pranayama yoga