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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03705780
Enrollment
104
Registered
2018-10-15
Start date
2018-06-21
Completion date
2018-11-09
Last updated
2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

fentanyl, OSAS screening scale, adenotonsillectomy, diagnose

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.

Interventions

OTHERthe short OSAS scale

Parents fill in the short OSAS screening scale in preoperative interview,calculate score of the scale.

DIAGNOSTIC_TESTfentanyl 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

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity, specificity ,positive predictive value and negative predictive value,likelihood ratio5 monthsCompared the diagnostic results of fentanyl test and the short OSAS screening scale with the diagnostic results of golden standard PSG.

Secondary

MeasureTime frameDescription
hydromorphone requirement in PACU50 minutes after extubationPain 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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026