Clinical trial NCT03127891: Effect of Yoga on Anesthesia Management
Official title: Effect of Short Term Pranayama on Anaesthesia Management in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Closed Loop Anesthesia Delivery System (CLADS)
Keywords: pranayama yoga
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Severe restrictive lung disease
* Severe obstructive lung disease
* NYHA-4
* Drug addicts
* History of smoking
* Alcohol intake
* Central nervous system disease
* Psychiatric disorder

Primary outcomes:
measure: 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.
timeFrame: minimum 5 days
measure: 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.
timeFrame: Minimum 5 days
measure: 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.
timeFrame: Minimum 5 days
Secondary outcomes:
measure: the effect of YOGA on pre operative anxiety. pre operative anxiety will be measured by STAI (state and trait anxiety inventory) scale
timeFrame: minimum 5 days preoperatively
measure: consumption of propofol
timeFrame: approx 8-12hrs
measure: Fentanyl consumption
timeFrame: approx 8-12 hrs
measure: vecuronium consumption
timeFrame: approx 8-12 hrs
measure: post-operative anxiety. Post operative anxiety will be measured by STAI (state and trait anxiety inventory) scale
timeFrame: at 12 hrs after extubation
measure: post-operative outcome (complications)
timeFrame: approx 7 days
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Aspari Mahammad Azeez
state: Apmc 77179
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Goverdhan D Puri, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: