Fentanyl Test and A Short OSAS Screening Scale for Severe Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The aim of this study was to estimate and compare the value of the preoperative fentanyl test and the short OSAS screening scale to diagnose severe obstructive sleep apnea；and to observe the required amount of hydromorphone and the adverse respiratory events after adenotonsillectomy.

Detailed Description
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The results of polysomnography were obtained before adenotonsillectomy, and the short OSAS screening scale was completed by the subjects' parents in preoperative interview. All children were induced by sevoflurane inhalation. After eyelash reflex disappeared and pharyngeal airway insertion, giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable, observing the changes of respiratory rate. Severe OSAS was diagnosed as respiratory rate decreased by more than 50%. Anesthesia was maintained with desflurane and 60% nitrous oxide in oxygen. The children were transferred to the PACU after extubation. The postoperative pain and agitation were assessed according to the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and The Pediatric Anesthesia Emergency Delirium (PAED) score, and all children were given hydromorphone for pain relief according to our protocol.

Official Title
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Comparison of Preoperative Fentanyl Test and A Short OSAS Screening Scale for Identifying Severe Obstructive Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: the short OSAS scale
* Diagnostic Test: fentanyl test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The American society of anesthesiologists (ASA) class Ⅰ   Ⅱ Age greater than or equal to 3 years Children were diagnosed by polysomnography and plan to adenotonsillectomy. Exclusion Criteria: craniofacial malformations mental retardation BMI > 30 kg/m2 Combined with other neuromuscular diseases a recent history of opioid use

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: the short OSAS scale<br>In preoperative interview，distributing the short OSAS screening scales to children's parents，and the scale was completed preoperative，calculate the score of the scale | Other: the short OSAS scale<br>* Parents fill in the short OSAS screening scale in preoperative interview，calculate score of the scale.<br>|
| Experimental: fentanyl test<br>In the operating room，giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable after eyelash reflex disappeared and pharyngeal airway insertion, observing the changes of respiratory rate | Diagnostic Test: fentanyl test<br>* In the operating room，giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable after eyelash reflex disappeared and pharyngeal airway insertion, observing the changes of respiratory rate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity， specificity ，positive predictive value and negative predictive value，likelihood ratio | Compared the diagnostic results of fentanyl test and the short OSAS screening scale with the diagnostic results of golden standard PSG. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hydromorphone requirement in PACU | Pain was assessed according to the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and hydromorphone of 2 µg/Kg was provided if the CHEOPS pain score was >6. The CHEOPS is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.It includes six categories of pain behavior, each with 3-4 levels. CHEOPS pain score = SUM(points for all 6 parameters) minimum score: 4 maximum score: 13 | 50 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, OSAS screening scale, adenotonsillectomy, diagnose