Remifentanil in Children With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— ROSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958396
• Other study ID #: 201504056
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: March 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

References & Publications (3)

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. — View 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. Review. — View 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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in end-expired carbon dioxide from baseline over time - OSA Group	End-expired carbon dioxide monitoring using bedside monitoring	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Primary	Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group	End-expired carbon dioxide monitoring using bedside monitoring	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Primary	Change in respiratory rate from baseline over time - OSA Group	Respiratory monitoring was performed using nasal cannula	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Primary	Change in respiratory rate from baseline over time - Control (non-OSA) Group	Respiratory monitoring was performed using nasal cannula	Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Primary	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.	Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Primary	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.	Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
Primary	Remifentanil plasma concentration - OSA Group	3ml blood draw	Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Primary	Remifentanil plasma concentration - Contro (non-OSA) Group	3ml blood draw	Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion