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

Early Phase 1CompletedNCT05051189

Baylor College of Medicine90 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

OSA Opioid Adenotonsillectomy

Interventions

Fentanyl CitrateDRUG

Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV

Eligibility

Sex: ALLMin age: 2 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Texas childrens Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Respiratory depression following opioids

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

Respiratory depression following opioids

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

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

Time frame: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

Data from ClinicalTrials.gov

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