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Clinical Trials/NCT03127891
NCT03127891CompletedNot Applicable

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

Post Graduate Institute of Medical Education and Research, Chandigarh2 sites in 1 country40 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
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.

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

control group

Placebo Comparator

no intervention

Intervention: control group (Other)

pranayama yoga

Experimental

yoga breathing exercise

Intervention: pranayama yoga (Behavioral)

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • the effect of YOGA on pre operative anxiety. pre operative anxiety will be measured by STAI (state and trait anxiety inventory) scale(minimum 5 days preoperatively)
  • Fentanyl consumption(approx 8-12 hrs)
  • vecuronium consumption(approx 8-12 hrs)
  • consumption of propofol(approx 8-12hrs)
  • post-operative anxiety. Post operative anxiety will be measured by STAI (state and trait anxiety inventory) scale(at 12 hrs after extubation)
  • post-operative outcome (complications)(approx 7 days)

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

aspari mahammad azeez

Junior resident, dept.of anesthesia and intensive care

Post Graduate Institute of Medical Education and Research, Chandigarh

Study Sites (2)

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