Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
- Registration Number
- NCT05051189
- Lead Sponsor
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg Fentanyl Citrate Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes. Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanyl Fentanyl Citrate Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg Fentanyl Citrate Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes. Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl Fentanyl Citrate Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.
- Primary Outcome Measures
Name Time Method Respiratory depression following opioids 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Texas childrens Hospital
🇺🇸Houston, Texas, United States