Hypotension on InductionNCT04603469
Hypotension in Children With Down Syndrome With Anesthesia Induction
An observational study of Hypotension on Induction, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 week to 18 years
- Conditions the study is for
- Hypotension on Induction
- What is being tested?
- Non invasive blood pressure
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 28 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- Children <18 years old Requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypotension on Induction
- Being tested
- Non invasive blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive blood pressureOther
Also called blood pressure
measurement of blood pressure during induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Trisomy 21 patients | Children <18 years old requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3 Receives: Other: Non invasive blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of non-invasive blood pressure during induction
non invasive blood pressure during induction (systolic, diastolic and Mean pressures)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start26 May 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
- Investigators
- Adam Adler, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603469
- Sponsor's protocol ID
- H-48044
- Status last verified
- Jul 2022
- First submitted
- 21 Oct 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypotension in Children With Down Syndrome During Induction of Anesthesia With Sevoflurane
- ClinicalTrials.gov ID
- NCT04603469
- Acronym / sponsor ID
- H-48044
- Conditions
- Hypotension on Induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trisomy 21 patients | – | Other: Non invasive blood pressureChildren <18 years old requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3 |
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- Children <18 years old Requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive blood pressureAlso: blood pressuremeasurement of blood pressure during induction of general anesthesia | Other | Trisomy 21 patients |
Primary outcome
Assessment of non-invasive blood pressure during induction
Time frame: 5 minutes
non invasive blood pressure during induction (systolic, diastolic and Mean pressures)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Adler, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of non-invasive blood pressure during induction (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.