Hypotension in Children With Down Syndrome With Anesthesia Induction

July 26, 2022 updated by: Adam Adler MD, MS, FAAP, Baylor College of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is an observational study of children with down syndrome undergoing induction of general anesthesia with sevoflurane. vital signs of blood pressure, heart rate and pulse oximetry will be recorded on the anesthesia record as standard practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trisomy 21 patients
Children <18 years old requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3
Other: Non invasive blood pressure
measurement of blood pressure during induction of general anesthesia
Other Names:
  • blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of non-invasive blood pressure during induction
Time Frame: 5 minutes
non invasive blood pressure during induction (systolic, diastolic and Mean pressures)
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 26, 2021

Primary Completion (ACTUAL)

October 28, 2021

Study Completion (ACTUAL)

October 28, 2021

Study Registration Dates

First Submitted

October 21, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (ACTUAL)

October 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-48044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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