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Trial record 1 of 5 for:    "Tetralogy of Fallot" | "Central Nervous System Depressants"
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Comparison of RVOT Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing TOF Repair

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ClinicalTrials.gov Identifier: NCT03234582
Recruitment Status : Unknown
Verified July 2017 by Dr. Dheemta Toshkhani, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Enrolling by invitation
First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Dheemta Toshkhani, Postgraduate Institute of Medical Education and Research

Brief Summary:
The primary objective of the study will be to compare intraoperative post TOF repair RVOT gradient under two different anaesthetic depths. Secondary objectives will be to follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow- up

Condition or disease
Tetralogy of Fallot

Detailed Description:

After completion of the TOF repair and rewarming to normothermia, all the patients will be assessed by TEE for adequacy of repair and separated from the cardiopulmonary bypass using vasopressors and inotropes. The choice of vasoactive and inotropic agents will be as per the requirement to maintain stable hemodynamics of the patients. Post bypass sevoflurane 1% end tidal concentration (0.5 MAC) will be used in all the patients. RV pressure and gradients across RVOT will be measured directly by placing a 23 gauge needle into the RV and pulmonary artery, and also by TEE using Bernoulli's equation by placing continuous Doppler across tricuspid regurgitation jet and RVOT, as is being routinely done for patients undergoing TOF repair. In addition, velocity time integral (VTI) across left ventricular outflow tract (LVOT) will also be recorded along with other hemodynamic parameters such as HR, SBP, DBP, MAP and SpO2. Subsequently, these measurements will be repeated again after increasing the sevoflurane to 2% end tidal concentration (1 MAC) and allowing the patients to stabilise on this new concentration for 5 minutes while maintaining systemic pressure within a range of 5% of the previous value. Normocarbia (EtCO2 30-35 mmHg) will be maintained during these measurements by adequate minute ventilation.

Following the surgery, all the patients will be shifted to cardio-surgical ICU and will be extubated once they meet the extubation criteria. Post-operative RVOT pressure gradient and RV functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at discharge from ICU and after 1 month of surgery on first follow-up. RV functions on echocardiography will be assessed using TAPSE (Tricuspid annular plane systolic excursion) and fractional RV area change during systole. The duration of post-operative mechanical ventilation, vasoactive inotropic score (VIS), PaO2/FiO2 ratio till discharge from ICU and any morbidity or adverse outcome during hospital stay will be noted.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Comparison of Right Ventricular Outflow Tract Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing Tetralogy of Fallot Repair
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Comparison of right ventricular outflow tract gradient under anaesthesia with post-operative gradient in patients undergoing tetralogy of Fallot repair [ Time Frame: 15 minutes ]
    The primary objective of the study will be to compare intra-operative post TOF repair RVOT gradient under two different anaesthetic depths


Secondary Outcome Measures :
  1. Comparison of change in right ventricular outflow tract gradient post-operatively in patients undergoing tetralogy of Fallot repair [ Time Frame: 1 month ]
    To follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes use post-operatively by vasoactive-inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow-up



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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All the children between 6 months to 16 years of age undergoing TOF repair will be included in the study.TOF patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.
Criteria

Inclusion Criteria:

  • All the children between 6 months to 16 years of age undergoing TOF repair will be included in the study.

Exclusion Criteria:

  • TOF patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234582


Locations
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India
Nandita Kakkar
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Dr. Dheemta Toshkhani, MD Postgraduate Institute of Medical Education and Research

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Responsible Party: Dr. Dheemta Toshkhani, Junior Resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03234582     History of Changes
Other Study ID Numbers: NK/3021/pH/110
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tetralogy of Fallot
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs