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Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

Primary Purpose

OSA, Opioid, Adenotonsillectomy

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fentanyl Citrate
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for OSA

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing tonsillectomy or adenotonsillectomy
  • Ages 2 to up to 8 years
  • Preoperative sleep study demonstrating obstructive sleep apnea
  • Intubation without medication (e.g. no propofol prior to intubation)
  • Requirement for airway instrumentation: LMA or ETT
  • Inhalation induction of anesthesia

Exclusion Criteria:

  • No obstructive sleep apnea
  • Central sleep apnea events >5/hour
  • IV induction of anesthesia
  • Syndromic patients
  • Known or suspected difficult airway
  • Allergy to Fentanyl
  • Known cardiovascular medications
  • Pulmonary hypertension
  • Total intravenous anesthesia required
  • Parental refusal

Sites / Locations

  • Texas childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with sleep apnea having oxygen Saturation >85%

Patients with sleep apnea having oxygen Saturation <85%

Arm Description

Children with OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes

Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes

Outcomes

Primary Outcome Measures

Respiratory depression following opioids
Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Respiratory depression following opioids
Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration
Respiratory depression following opioids
Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration

Secondary Outcome Measures

Full Information

First Posted
September 2, 2021
Last Updated
March 6, 2023
Sponsor
Baylor College of Medicine
Collaborators
University of Houston, Children's Hospital of Philadelphia, Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT05051189
Brief Title
Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
Official Title
Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
University of Houston, Children's Hospital of Philadelphia, Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity
Detailed Description
Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in children suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. However, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. The aim of this study is to identify if children with known OSA experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Opioid, Adenotonsillectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
2 groups will be identified- patients with sleep study O2 nadir >85% patients with sleep study O2 nadir <85%
Masking
Participant
Masking Description
The participant will be unaware of the arm
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with sleep apnea having oxygen Saturation >85%
Arm Type
Active Comparator
Arm Description
Children with OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Arm Title
Patients with sleep apnea having oxygen Saturation <85%
Arm Type
Active Comparator
Arm Description
Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Intervention Type
Drug
Intervention Name(s)
Fentanyl Citrate
Intervention Description
Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV
Primary Outcome Measure Information:
Title
Respiratory depression following opioids
Description
Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Time Frame
respiratory rate measured at each minute for 10 consecutive minutes following opioid administration
Title
Respiratory depression following opioids
Description
Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration
Time Frame
tidal volume measured at each minute for 10 consecutive minutes following opioid administration
Title
Respiratory depression following opioids
Description
Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration
Time Frame
end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing tonsillectomy or adenotonsillectomy Ages 2 to up to 8 years Preoperative sleep study demonstrating obstructive sleep apnea Intubation without medication (e.g. no propofol prior to intubation) Requirement for airway instrumentation: LMA or ETT Inhalation induction of anesthesia Exclusion Criteria: No obstructive sleep apnea Central sleep apnea events >5/hour IV induction of anesthesia Syndromic patients Known or suspected difficult airway Allergy to Fentanyl Known cardiovascular medications Pulmonary hypertension Total intravenous anesthesia required Parental refusal
Facility Information:
Facility Name
Texas childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Adler, MD
Phone
832-824-5800
Email
axadler@texaschildrens.org
First Name & Middle Initial & Last Name & Degree
Kim Mayfield
Phone
8328245800
Email
kxmayfie@texaschildrens.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available at the conclusion of the study upon reasonable written request to the PI
IPD Sharing Time Frame
De-identified raw data will be available upon study completion following written request to the PI. There will be no time restriction on data
IPD Sharing Access Criteria
Written request
Citations:
PubMed Identifier
34053151
Citation
Adler AC, Chandrakantan A, Nathanson BH, von Ungern-Sternberg BS. An assessment of opioids on respiratory depression in children with and without obstructive sleep apnea. Paediatr Anaesth. 2021 Sep;31(9):977-984. doi: 10.1111/pan.14228. Epub 2021 Jun 16.
Results Reference
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Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

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