AzTrials
AzTrials

AnesthesiayogaNCT03127891

Effect of Yoga on Anesthesia Management

A study testing pranayama yoga in people with Anesthesia and Closed Loop Anesthesia Delivery System (CLADS), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
pranayama yoga
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteIndia
Study dates
Nov 2016to 31 May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site
  • Aspari Mahammad Azeez

    Chandigarh, Apmc 77179, 160012

Other trials in India

About this study

Official title: Effect of Short Term Pranayama on Anaesthesia Management in Patients Undergoing Cardiac Surgery

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.

Read more

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.

Being tested
pranayama yoga, control group
Keywords
pranayama yoga

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pranayama yogaBehavioural

    Also called yoga breathing exerxises

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

  • control groupOther

    no intervention should be given to patients allocated to this group

Study groups in NCT03127891
Study groupRoleWhat they receive
pranayama yogaExperimentalyoga breathing exercise
Receives: Behavioral: pranayama yoga
control groupPlacebo comparatorno intervention
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: Minimum 5 days

Secondary outcomes (6)
  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

    Measured: minimum 5 days preoperatively

  2. consumption of propofol

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

    Measured: approx 8-12hrs

  3. Fentanyl consumption

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

    Measured: approx 8-12 hrs

  4. vecuronium consumption

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

    Measured: 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

    Measured: at 12 hrs after extubation

  6. post-operative outcome (complications)

    post operative complications related to surgery and anesthesia

    Measured: approx 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study startNov 2016
  3. Primary completion20 May 2018
  4. Study completion31 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03127891
Sponsor's protocol ID
NK/3047/MD/807
Acronym
yoga
Status last verified
Sep 2018
First submitted
8 Jan 2017
Last updated
5 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing pranayama yoga in people with Anesthesia and Closed Loop Anesthesia Delivery System (CLADS), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: minimum 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in