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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Diagnostic Test: fentanyl test; Other: the short OSAS scale

• Registration Number: NCT03705780
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-06-21
• Study First Submitted: 2018-09-25
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. The American society of anesthesiologists (ASA) class Ⅰ ~ Ⅱ
2. Age greater than or equal to 3 years
3. Children were diagnosed by polysomnography and plan to adenotonsillectomy.

Exclusion Criteria

1. craniofacial malformations
2. mental retardation
3. BMI > 30 kg/m2
4. Combined with other neuromuscular diseases
5. a recent history of opioid use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
fentanyl test	fentanyl test	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
the short OSAS scale	the short OSAS scale	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

Primary Outcome Measures

Name	Time	Method
Sensitivity， specificity ，positive predictive value and negative predictive value，likelihood ratio	5 months	Compared the diagnostic results of fentanyl test and the short OSAS screening scale with the diagnostic results of golden standard PSG.

Secondary Outcome Measures

Name	Time	Method
hydromorphone requirement in PACU	50 minutes after extubation	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

Trial Locations

Locations (1)

Chilren's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China