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Remifentanil in Children With Obstructive Sleep Apnea (ROSA)

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Remifentanil Infusion

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

OSA Group

Control (non-OSA) Group

Arm Description

a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

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

Outcomes

Primary Outcome Measures

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

End-expired carbon dioxide monitoring using bedside monitoring

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

End-expired carbon dioxide monitoring using bedside monitoring

Change in respiratory rate from baseline over time - OSA Group

Respiratory monitoring was performed using nasal cannula

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

Respiratory monitoring was performed using nasal cannula

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.

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.

Remifentanil plasma concentration - OSA Group

3ml blood draw

Remifentanil plasma concentration - Contro (non-OSA) Group

3ml blood draw

Secondary Outcome Measures

Full Information

NCT ID

NCT03958396

First Posted

May 16, 2019

Last Updated

March 10, 2020

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03958396

Brief Title

Remifentanil in Children With Obstructive Sleep Apnea

Acronym

ROSA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2015 (Actual)

Primary Completion Date

October 31, 2017 (Actual)

Study Completion Date

October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Parallel group study comparing patients with obstructive sleep apnea undergoing tonsillectomy or tonsillectomy and adenoidectomy to controls with no history of obstructive sleep apnea undergoing general anesthesia for any procedure. The study will be conducted in the patient's preoperative holding area room. Two intravenous catheters will be placed, one for a remifentanil infusion and one for blood draws to measure the blood concentration of remifentanil. Patients will have standard ASA monitors placed with vital signs monitored on a portable monitor, and a remifentanil infusion will be started. Blood draws will be taken at seven time points: zero, one, two, four, six, ten and fifteen minutes. Concomitantly, recordings of end tidal CO2, respiratory rate, and pupil diameter will be made at the seven time points.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OSA Group

Arm Type

Active Comparator

Arm Description

a) Children 8-14 years old, b) ASA physical status 1or 2, c) undergoing tonsillectomy or tonsillectomy and adenoidectomy for known obstructive sleep apnea

Arm Title

Control (non-OSA) Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Remifentanil Infusion

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Title

Change in respiratory rate from baseline over time - OSA Group

Description

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

Title

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

Description

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

Title

Change in pupil diameter from baseline over time - OSA Group

Description

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

Title

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

Description

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

Title

Remifentanil plasma concentration - OSA Group

Description

3ml blood draw

Time Frame

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

Title

Remifentanil plasma concentration - Contro (non-OSA) Group

Description

3ml blood draw

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anshuman Sharma, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

21539679

Citation

Brown KA. Outcome, risk, and error and the child with obstructive sleep apnea. Paediatr Anaesth. 2011 Jul;21(7):771-80. doi: 10.1111/j.1460-9592.2011.03597.x. Epub 2011 May 3.

Results Reference

result

PubMed Identifier

22926176

Citation

Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.

Results Reference

result

PubMed Identifier

20974339

Citation

Bhattacharyya N, Lin HW. Changes and consistencies in the epidemiology of pediatric adenotonsillar surgery, 1996-2006. Otolaryngol Head Neck Surg. 2010 Nov;143(5):680-4. doi: 10.1016/j.otohns.2010.06.918.

Results Reference

result

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Remifentanil in Children With Obstructive Sleep Apnea

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