Hypotension in Children With Down Syndrome With Anesthesia Induction

Completed

• Conditions: Hypotension on Induction
• Interventions: Other: Non invasive blood pressure

• Registration Number: NCT04603469
• Lead Sponsor: Baylor College of Medicine

Brief 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.

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 Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-26
• Study Start: 2021-05-26
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trisomy 21 patients	Non invasive blood pressure	Children \<18 years old requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3

Primary Outcome Measures

Name	Time	Method
Assessment of non-invasive blood pressure during induction	5 minutes	non invasive blood pressure during induction (systolic, diastolic and Mean pressures)

Trial Locations

Locations (1)

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States