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NCT04603469 Clinical Trial

Hypotension in Children With Down Syndrome With Anesthesia Induction

Hypotension on Induction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04603469
Other study ID # H-48044
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 26, 2021
Est. completion date October 28, 2021

Study information
Verified date July 2022
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date October 28, 2021
Est. primary completion date October 28, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Week to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non invasive blood pressure
measurement of blood pressure during induction of general anesthesia

Locations
Country Name City State
United States Texas Childrens Hospital Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of non-invasive blood pressure during induction non invasive blood pressure during induction (systolic, diastolic and Mean pressures) 5 minutes
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