Hypotension in Children With Down Syndrome With Anesthesia Induction

NCT04603469 | Completed

• 1 other identifier: H-48044
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension on Induction

Outcome Measures

Primary Outcomes (1)

• Assessment of non-invasive blood pressure during induction

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

  5 minutes

Study Arms (1)

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

Interventions

Non invasive blood pressure OTHER

measurement of blood pressure during induction of general anesthesia

Also known as: blood pressure

Trisomy 21 patients

Eligibility Criteria

• Age: 1 Week - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Blood Pressure

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Adam Adler, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 26, 2020
• Study Start: May 26, 2021
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)