NCT03127891

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. 1.To compare the effect of YOGA on preoperative anxiety.
  2. 2.To compare the effect of Yoga on SPO2.
  3. 3.To compare effect of Yoga on total consumption of propofol administered using Closed Loop Anaesthesia Delivery system(CLADS)
  4. 4.To compare effect of Yoga on total consumption of fentanyl, and vecuronium
  5. 5.To compare effect of Yoga on post-operative anxiety (after extubation in CTVS ward)
  6. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

January 8, 2017

Last Update Submit

September 3, 2018

Conditions

AnesthesiaClosed Loop Anesthesia Delivery System (CLADS)

Keywords

pranayama yoga

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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

    minimum 5 days preoperatively

  • consumption of propofol

    approx 8-12hrs

  • Fentanyl consumption

    approx 8-12 hrs

  • vecuronium consumption

    approx 8-12 hrs

  • post-operative anxiety. Post operative anxiety will be measured by STAI (state and trait anxiety inventory) scale

    at 12 hrs after extubation

  • +1 more secondary outcomes

Study Arms (2)

pranayama yoga

EXPERIMENTAL

yoga breathing exercise

Behavioral: pranayama yoga

control group

PLACEBO COMPARATOR

no intervention

Other: control group

Interventions

pranayama yogaBEHAVIORAL

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

Also known as: yoga breathing exerxises
pranayama yoga
control groupOTHER

no intervention should be given to patients allocated to this group

control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspari Mahammad Azeez

Chandigarh, Apmc 77179, 160012, India

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Goverdhan D Puri, MD,PhD

    Post Graduate Institute of Medical Education and Research, Chandigarh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior resident, dept.of anesthesia and intensive care

Study Record Dates

First Submitted

January 8, 2017

First Posted

April 25, 2017

Study Start

November 1, 2016

Primary Completion

May 20, 2018

Study Completion

May 31, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)