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

NCT03705780 | Completed

• 1 other identifier: FTASOSSSOSP
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

fentanyl; OSAS screening scale; adenotonsillectomy; diagnose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• hydromorphone requirement in PACU

  50 minutes after extubation

Study Arms (2)

the short OSAS scale

OTHER

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

fentanyl test

EXPERIMENTAL

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

Interventions

the short OSAS scale OTHER

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

the short OSAS 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

fentanyl test

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• craniofacial malformations
• mental retardation
• BMI \> 30 kg/m2
• Combined with other neuromuscular diseases
• a recent history of opioid use

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Xuan Wang

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，Head of Anesthesiology

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 15, 2018
• Study Start: June 21, 2018
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: December 13, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)