Remifentanil in Children With Obstructive Sleep Apnea

NCT03958396 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 201504056
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

OSA Group

ACTIVE COMPARATOR

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

Drug: Remifentanil Infusion

Control (non-OSA) Group

ACTIVE COMPARATOR

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

Drug: Remifentanil Infusion

Interventions

Remifentanil Infusion DRUG

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

Control (non-OSA) Group; OSA Group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)
• Control (Non-OSA) Group:
• years old
• ASA physical status 1 or 2
• no known obstructive sleep apnea presenting for any procedure requiring general anesthtic
• Inability to cooperate with study requirements (IV placement, sitting quietly, wearing goggles, etc.)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Publications (3)

• 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.

  PMID: 21539679 RESULT

• 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.

  PMID: 22926176 RESULT

• 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.

  PMID: 20974339 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Anshuman Sharma, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 22, 2019
• Study Start: September 1, 2015
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: March 12, 2020

Record last verified: 2020-03