Hypotension in Children With Down Syndrome With Anesthesia Induction

NCT ID: NCT04603469

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-26

Study Completion Date

2021-10-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypotension on Induction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trisomy 21 patients

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

Non invasive blood pressure

Intervention Type OTHER

measurement of blood pressure during induction of general anesthesia

Interventions

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Non invasive blood pressure

measurement of blood pressure during induction of general anesthesia

Intervention Type OTHER

Other Intervention Names

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blood pressure

Eligibility Criteria

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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
Minimum Eligible Age

1 Week

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Adam Adler MD, MS, FAAP

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Adler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Texas Childrens Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H-48044

Identifier Type: -

Identifier Source: org_study_id

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