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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051189
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : December 28, 2021
Sponsor:
Information provided by (Responsible Party):
Adam Adler MD, MS, FAAP, Baylor College of Medicine

Brief Summary:
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity

Condition or disease Intervention/treatment Phase
OSA Opioid Adenotonsillectomy Drug: Fentanyl Citrate Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 groups will be identified-

  1. patients with sleep study O2 nadir >85%
  2. patients with sleep study O2 nadir <85%
Masking: Single (Participant)
Masking Description: The participant will be unaware of the arm
Primary Purpose: Diagnostic
Official Title: Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Patients with sleep apnea having oxygen Saturation >85%
Children with OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Drug: Fentanyl Citrate
Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV

Active Comparator: Patients with sleep apnea having oxygen Saturation <85%
Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Drug: Fentanyl Citrate
Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV




Primary Outcome Measures :
  1. Respiratory depression following opioids [ Time Frame: respiratory rate measured at each minute for 10 consecutive minutes following opioid administration ]
    Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration

  2. Respiratory depression following opioids [ Time Frame: tidal volume measured at each minute for 10 consecutive minutes following opioid administration ]
    Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration

  3. Respiratory depression following opioids [ Time Frame: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration ]
    Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051189


Locations
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United States, Texas
Texas childrens Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Adam Adler, MD    832-824-5800    axadler@texaschildrens.org   
Contact: Kim Mayfield    8328245800    kxmayfie@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
Publications of Results:
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Responsible Party: Adam Adler MD, MS, FAAP, Associate Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05051189    
Other Study ID Numbers: H50267
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available at the conclusion of the study upon reasonable written request to the PI
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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
Access Criteria: Written request

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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
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics