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

OSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051189
• Other study ID #: H50267
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenotonsillectomy
• Opioid
• OSA
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Texas childrens Hospital	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Baylor College of Medicine	Children's Hospital of Philadelphia, University of Houston, Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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