Clinical trial NCT03958396: Remifentanil in Children With Obstructive Sleep Apnea
Official title: The Pharmacokinetic and Pharmacodynamics Profiles of Remifentanil in Children With Obstructive Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Obstructive Sleep Apnea
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: Change in end-expired carbon dioxide from baseline over time - OSA Group
timeFrame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
measure: Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group
timeFrame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
measure: Change in respiratory rate from baseline over time - OSA Group
timeFrame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
measure: Change in respiratory rate from baseline over time - Control (non-OSA) Group
timeFrame: Approximately 1 hour before surgery - Measurements taken at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
measure: Change in pupil diameter from baseline over time - OSA Group
timeFrame: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
measure: Change in pupil diameter from baseline over time - Control (non-OSA) Group
timeFrame: Approximately 1 hour before surgery - Measured continuously and averaged into 10-s bins following remefentanil infusion
measure: Remifentanil plasma concentration - OSA Group
timeFrame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
measure: Remifentanil plasma concentration - Contro (non-OSA) Group
timeFrame: Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Anshuman Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.