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CompletedNCT03127891yogaUpdated Sep 5, 2018

Effect of Yoga on Anesthesia Management

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Anesthesia
  • Closed Loop Anesthesia Delivery System (CLADS)

Keywords

  • pranayama yoga
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    pranayama yoga

    yoga breathing exercise

    Behavioral: pranayama yoga

  • Placebo comparator
    control group

    no intervention

    Other: control group

Interventions

  • Behavioralpranayama yoga

    providing short term pranayama yoga for 5 sessions before surgery patients under going cardiac surgery.

    Also known as: yoga breathing exerxises

  • Othercontrol group

    no intervention should be given to patients allocated to this group

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. consumption of propofol

    intra operative consumption of opioid propofol consumption during induction and maintenance of anesthesia

    Time frame: approx 8-12hrs

  3. Fentanyl consumption

    intra operative consumption of opioid fentanyl consumption during induction and maintenance of anesthesia

    Time frame: approx 8-12 hrs

  4. vecuronium consumption

    intra operative consumption of muscle relaxant vecuronium during induction and maintenance of anesthesia

    Time frame: approx 8-12 hrs

  5. 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

  6. post-operative outcome (complications)

    post operative complications related to surgery and anesthesia

    Time frame: approx 7 days

07

Study locations

1 site
  • Aspari Mahammad Azeez
    Chandigarh, Apmc 77179 160012, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03127891
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible party
aspari mahammad azeez (Junior resident, dept.of anesthesia and intensive care, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
Apr 25, 2017
Start date
Nov 2016
Primary completion
May 20, 2018
Completion
May 31, 2018
Last update
Sep 5, 2018

Study contacts

Goverdhan D Puri, MD,PhD
principal investigator · Post Graduate Institute of Medical Education and Research, Chandigarh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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