Clinical trial NCT05051189: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: OSA
Opioid
Adenotonsillectomy
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Houston
name: Children's Hospital of Philadelphia
name: Wake Forest University
First posted: 2021-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups will be identified-

1. patients with sleep study O2 nadir \>85%
2. patients with sleep study O2 nadir \<85%
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Respiratory depression following opioids
timeFrame: respiratory rate measured at each minute for 10 consecutive minutes following opioid administration
measure: Respiratory depression following opioids
timeFrame: tidal volume measured at each minute for 10 consecutive minutes following opioid administration
measure: Respiratory depression following opioids
timeFrame: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas childrens Hospital
state: Texas
Study officials:
References:
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.