Obstructive Sleep Apnea
Conditions
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.
Interventions
15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in end-expired carbon dioxide from baseline over time - OSA Group | 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 |
| Change in end-expired carbon dioxide from baseline over time - Control (non-OSA) Group | 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 |
| Change in respiratory rate from baseline over time - OSA Group | 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 |
| Change in respiratory rate from baseline over time - Control (non-OSA) Group | 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 |
| Change in pupil diameter from baseline over time - OSA Group | 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. |
| Change in pupil diameter from baseline over time - Control (non-OSA) Group | 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. |
| Remifentanil plasma concentration - OSA Group | Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion | 3ml blood draw |
| Remifentanil plasma concentration - Contro (non-OSA) Group | Approximately 1 hour before surgery - Blood draws at 0, 1, 2, 4, 6, 10 & 15 minutes following remefentanil infusion | 3ml blood draw |
Outcome results
None listed