An Early Phase 1 interventional study of Remifentanil Infusion in Obstructive Sleep Apnea, sponsored by Washington University School of Medicine. Completed. Open to participants aged 8 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-12.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Treatment
This investigation tested the hypothesis that children with obstructive sleep apnea have an increased pharmacodynamic sensitivity to the miotic and respiratory depressant effects of the prototypic μ-opioid agonist remifentanil.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
OSA Group:
Inclusion Criteria:
Exclusion Criteria:
Control (Non-OSA) Group:
Inclusion Criteria:
Exclusion Criteria:
a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea
Drug: Remifentanil Infusion
a) Children 8-14 years old, b) ASA physical status 1or 2, c) no known obstructive sleep apnea presenting for any procedure requiring general anesthetic
Drug: Remifentanil Infusion
15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min
Change in end-expired carbon dioxide from baseline over time - OSA Group
End-expired carbon dioxide monitoring using bedside monitoring
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group
End-expired carbon dioxide monitoring using bedside monitoring
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in respiratory rate from baseline over time - OSA Group
Respiratory monitoring was performed using nasal cannula
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in respiratory rate from baseline over time - Control (non-OSA) Group
Respiratory monitoring was performed using nasal cannula
Time frame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Change in pupil diameter from baseline over time - OSA Group
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Time frame: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Change in pupil diameter from baseline over time - Control (non-OSA) Group
Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Time frame: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Remifentanil plasma concentration - OSA Group
3ml blood draw
Time frame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Remifentanil plasma concentration - Contro (non-OSA) Group
3ml blood draw
Time frame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
No study locations are listed for this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine