Remifentanil in Children With Obstructive Sleep Apnea

Early Phase 1

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Remifentanil Infusion

• Registration Number: NCT03958396
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 8-14 years old
• ASA physical status 1 or 2
• undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

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Exclusion Criteria

• Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)

Control (Non-OSA) Group:

Inclusion Criteria:

• 8-14 years old
• ASA physical status 1 or 2
• no known obstructive sleep apnea presenting for any procedure requiring general anesthtic

Exclusion Criteria:

• Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (non-OSA) Group	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
OSA Group	Remifentanil Infusion	a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

Primary Outcome Measures

Name	Time	Method
Change in respiratory rate from baseline over time - OSA Group	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion	Respiratory monitoring was performed using nasal cannula
Change in pupil diameter from baseline over time - OSA Group	Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion	Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Change in pupil diameter from baseline over time - Control (non-OSA) Group	Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion	Dark adapted infrared pupillometry performed using binocular infrared pupilometer mounted in light occlusive goggles sampling at 100 Hz.
Change in end-expired carbon dioxide from baseline over time - OSA Group	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion	End-expired carbon dioxide monitoring using bedside monitoring
Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion	End-expired carbon dioxide monitoring using bedside monitoring
Change in respiratory rate from baseline over time - Control (non-OSA) Group	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion	Respiratory monitoring was performed using nasal cannula
Remifentanil plasma concentration - OSA Group	Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion	3ml blood draw
Remifentanil plasma concentration - Contro (non-OSA) Group	Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion	3ml blood draw