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

Study Overview
=================
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.

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

Conditions
-----------------
OSA, Opioid, Adenotonsillectomy

Intervention / Treatment
-----------------
* Drug: Fentanyl Citrate


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups will be identified- patients with sleep study O2 nadir >85% patients with sleep study O2 nadir <85%
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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 | end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration |