Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03127891
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2017-01-08
Brief Title:
Effect of Yoga on Anesthesia Management
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Effect of Short Term Pranayama on Anaesthesia Management in Patients Undergoing Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
yoga
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 systemCLADS
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
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 systemCLADS
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 Spielbergs 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 SPO2of 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 HeShe 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 allowsThe 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 headEyes will be closed gently
1 The patients will be instructed to open their mouth and stretch the tongue as long as heshe 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 headEyes 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 participants 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 SPO2of 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 iv 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 SAnesthesia monitor Datex Ohmeda Inc Madison WI and continuous BIS BIS XP Aspect Medical Systems Newton MA in the S5 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 mcgkg in both groups Muscular paralysis for tracheal intubation will be achieved by vecuronium bromide 01mgkg followed by intermittent boluses After intubation volume-controlled mechanical ventilation to be provided with FiO2 05 tidal volume 7-8 mlkg positive end-expiratory pressure PEEP 5 cm H2O and respiratory rate of 12-14min Patients will be mechanically ventilated with air oxygen mixture 5050 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 10 mcgkgh will be administered for analgesia Fentanyl 1 mcgkg 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 mgkg titrated to the ACT of 450 secondsEvery 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 mlkghr prior to and during anesthesia and 2- 3 mlkghr postoperatively All the anesthesia drug consumption data will be recorded online using CLADS
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 Spielbergs 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 SPO2of 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 HeShe 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 allowsThe 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 headEyes will be closed gently
1 The patients will be instructed to open their mouth and stretch the tongue as long as heshe 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 headEyes 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 participants 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 SPO2of 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 iv 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 SAnesthesia monitor Datex Ohmeda Inc Madison WI and continuous BIS BIS XP Aspect Medical Systems Newton MA in the S5 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 mcgkg in both groups Muscular paralysis for tracheal intubation will be achieved by vecuronium bromide 01mgkg followed by intermittent boluses After intubation volume-controlled mechanical ventilation to be provided with FiO2 05 tidal volume 7-8 mlkg positive end-expiratory pressure PEEP 5 cm H2O and respiratory rate of 12-14min Patients will be mechanically ventilated with air oxygen mixture 5050 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 10 mcgkgh will be administered for analgesia Fentanyl 1 mcgkg 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 mgkg titrated to the ACT of 450 secondsEvery 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 mlkghr prior to and during anesthesia and 2- 3 mlkghr postoperatively All the anesthesia drug consumption data will be recorded online using CLADS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None