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Completed

NCT Number: NCT03958396

Remifentanil in Children With Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Remifentanil infusion

Drug

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

Primary outcomes

  1. Change in end-expired carbon dioxide from baseline over time - OSA Group

    Time frame: 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

  2. Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group

    Time frame: 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

  3. Change in respiratory rate from baseline over time - OSA Group

    Time frame: 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

  4. Change in respiratory rate from baseline over time - Control (non-OSA) Group

    Time frame: 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

  5. Change in pupil diameter from baseline over time - OSA Group

    Time frame: 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.

  6. Change in pupil diameter from baseline over time - Control (non-OSA) Group

    Time frame: 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.

  7. Remifentanil plasma concentration - OSA Group

    Time frame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion

    3ml blood draw

  8. Remifentanil plasma concentration - Contro (non-OSA) Group

    Time frame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion

    3ml blood draw

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

The Pharmacokinetic and Pharmacodynamics Profiles of Remifentanil in Children With Obstructive Sleep Apnea.

Acronym: ROSA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 22, 2019
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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