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OpenTrials
Completed

NCT Number: NCT04603469

Hypotension in Children With Down Syndrome With Anesthesia Induction

Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

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Key information

Age range

1 week–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Childrens Hospital

Houston, Texas, 77030, United States

About this study

Children generally undergo induction of anesthesia by inhalation of sevoflurane. This is particularly relevant for children with developmental delays as to avoid placement of an IV while awake. However, children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children <18 years old Requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3

Exclusion criteria

Patients >18 years of age Patients without down syndrome Cyanotic congenital heart disease Use of antihypertensive medications Pulmonary hypertension patients undergoing intravenous induction of anesthesia ASA physical classification other than 1-3 emergency procedure

Treatment and study plan

Non invasive blood pressure

Other

measurement of blood pressure during induction of general anesthesia

Other names: blood pressure

Primary outcomes

  1. Assessment of non-invasive blood pressure during induction

    Time frame: 5 minutes

    non invasive blood pressure during induction (systolic, diastolic and Mean pressures)

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Incidence of Hypotension in Children With Down Syndrome During Induction of Anesthesia With Sevoflurane

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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