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.
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
- Conditions the study is for
- Anesthesia, Closed Loop Anesthesia Delivery System (CLADS)
- What is being tested?
- pranayama yoga
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- To compare the effect of YOGA on preoperative anxiety.
- To compare the effect of Yoga on SPO2.
- To compare effect of Yoga on total consumption of propofol administered using Closed Loop Anaesthesia Delivery system(CLADS)
- To compare effect of Yoga on total consumption of fentanyl, and vecuronium
- To compare effect of Yoga on post-operative anxiety (after extubation in CTVS ward)
- 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 )
- The patient will be made to sit in a comfortable posture with spine erect and in line with neck and head.
- He/She will be instructed to put the hands in Gyan mudra and eyes closed.
- Being aware of their breath, the participant will be instructed to breathe deeply through the nose.
- During exhalation "AUM" will be chanted for as long as their body allows.The participant will not be stressed.
Nadishodhana Pranayama (10 minutes)
- The patient will be made to sit in a comfortable posture with spine erect and in line with neck and head
- 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
- The participant will be made to close the eyes.
- The right nostril will be closed and deep inhalation will be taken from the left nostril.
- The left nostril will be closed and exhalation will be carried out through the right nostril.
- Inhalation will be done through right nostril keeping the left nostril closed.
- Exhalation will be done through left nostril keeping the right nostril closed.
- 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.
- The patients will be instructed to open their mouth and stretch the tongue as long as he/she can.
- The tongue will be rolled from sides such that tongue takes the form of a hollow tube.
- Air will be inhaled through this hollow tube.
- Later, the mouth will be closed and exhalation will be carried out through the nose.
Bhramari Pranayama ( 10 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.
- The hands will be preferably kept in Shanmukhi mudra. If not comfortable, Gyan mudra will have opted and eyes will be kept closed.
- Being aware of their breath, the participant will be instructed to breathe deeply through nose
- During exhalation, humming sound will be produced for as long as the participant's body allows. They will not be stressed.
- 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 group | Role | What they receive |
|---|---|---|
| pranayama yoga | Experimental | yoga breathing exercise Receives: Behavioral: pranayama yoga |
| control group | Placebo comparator | no intervention Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
consumption of propofol
intra operative consumption of opioid propofol consumption during induction and maintenance of anesthesia
Measured: approx 8-12hrs
Fentanyl consumption
intra operative consumption of opioid fentanyl consumption during induction and maintenance of anesthesia
Measured: approx 8-12 hrs
vecuronium consumption
intra operative consumption of muscle relaxant vecuronium during induction and maintenance of anesthesia
Measured: 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
Measured: at 12 hrs after extubation
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.
- First posted25 Apr 2017
- Study startNov 2016
- Primary completion20 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aspari mahammad azeez, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Goverdhan D Puri, MD,PhD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short Term Pranayama on Anaesthesia Management in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03127891
- Acronym / sponsor ID
- yoga / NK/3047/MD/807
- Keywords
- pranayama yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To compare the effect of YOGA on preoperative anxiety.
- To compare the effect of Yoga on SPO2.
- To compare effect of Yoga on total consumption of propofol administered using Closed Loop Anaesthesia Delivery system(CLADS)
- To compare effect of Yoga on total consumption of fentanyl, and vecuronium
- To compare effect of Yoga on post-operative anxiety (after extubation in CTVS ward)
- 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 )
- The patient will be made to sit in a comfortable posture with spine erect and in line with neck and head.
- He/She will be instructed to put the hands in Gyan mudra and eyes closed.
- Being aware of their breath, the participant will be instructed to breathe deeply through the nose.
- During exhalation "AUM" will be chanted for as long as their body allows.The participant will not be stressed.
Nadishodhana Pranayama (10 minutes)
- The patient will be made to sit in a comfortable posture with spine erect and in line with neck and head
- 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
- The participant will be made to close the eyes.
- The right nostril will be closed and deep inhalation will be taken from the left nostril.
- The left nostril will be closed and exhalation will be carried out through the right nostril.
- Inhalation will be done through right nostril keeping the left nostril closed.
- Exhalation will be done through left nostril keeping the right nostril closed.
- 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.
- The patients will be instructed to open their mouth and stretch the tongue as long as he/she can.
- The tongue will be rolled from sides such that tongue takes the form of a hollow tube.
- Air will be inhaled through this hollow tube.
- Later, the mouth will be closed and exhalation will be carried out through the nose.
Bhramari Pranayama ( 10 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.
- The hands will be preferably kept in Shanmukhi mudra. If not comfortable, Gyan mudra will have opted and eyes will be kept closed.
- Being aware of their breath, the participant will be instructed to breathe deeply through nose
- During exhalation, humming sound will be produced for as long as the participant's body allows. They will not be stressed.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pranayama yoga | Experimental | Behavioral: pranayama yogayoga breathing exercise |
| control group | Placebo comparator | Other: control groupno intervention |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 20-60y
- Cardiac surgery( valvular heart disease and coronary artery disease)
Key exclusion criteria (8 listed)
- Severe restrictive lung disease
- Severe obstructive lung disease
- NYHA-4
- Drug addicts
- History of smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pranayama yogaAlso: yoga breathing exerxisesproviding short term pranayama yoga for 5 sessions before surgery patients under going cardiac surgery. | Behavioural | pranayama yoga |
| control groupno intervention should be given to patients allocated to this group | Other | control group |
Primary outcome
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
Heart rate will be measured before and after every yoga session for 5 consecutive 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.
Time frame: Minimum 5 days
Mean arterial pressure will be measured before and after every yoga session for 5 consecutive 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.
Time frame: Minimum 5 days
SpO2 will be measured before and after every yoga session for 5 consecutive days
6 secondary outcomes
the effect of YOGA on pre operative anxiety. pre operative anxiety will be measured by STAI (state and trait anxiety inventory) scale
Time frame: minimum 5 days preoperatively
consumption of propofol
Time frame: approx 8-12hrs
Fentanyl consumption
Time frame: approx 8-12 hrs
vecuronium consumption
Time frame: approx 8-12 hrs
post-operative anxiety. Post operative anxiety will be measured by STAI (state and trait anxiety inventory) scale
Time frame: at 12 hrs after extubation
post-operative outcome (complications)
Time frame: approx 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goverdhan D Puri, MD,PhD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
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.