Remifentanil in Children With Obstructive Sleep Apnea

Early Phase 1CompletedNCT03958396

Washington University School of Medicine30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Remifentanil InfusionDRUG

15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min

Eligibility

Sex: ALLMin age: 8 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

OSA Group: Inclusion Criteria: * 8-14 years old * ASA physical status 1 or 2 * undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea 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.)

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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