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Completed

NCT Number: NCT03705780

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Disease Dyssomnias Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the short OSAS scale

Other

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

fentanyl test

Diagnostic 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

Primary outcomes

  1. Sensitivity， specificity ，positive predictive value and negative predictive value，likelihood ratio

    Time frame: 5 months

    Compared the diagnostic results of fentanyl test and the short OSAS screening scale with the diagnostic results of golden standard PSG.

Secondary outcomes

  1. hydromorphone requirement in PACU

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 15, 2018
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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