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Trial record 24 of 83 for:    PEELING SKIN SYNDROME

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

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ClinicalTrials.gov Identifier: NCT03705780
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Xuan Wang, 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: the short OSAS scale Diagnostic Test: fentanyl test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Preoperative Fentanyl Test and A Short OSAS Screening Scale for Identifying Severe Obstructive Sleep Apnea Syndrome
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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
Other: the short OSAS scale
Parents fill in the short OSAS screening scale in preoperative interview,calculate score of the scale.

Experimental: 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
Diagnostic 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




Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705780


Locations
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China, Shanghai
Chilren's Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Principal Investigator: Xuan Wang Children's Hospital of Fudan University

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Responsible Party: Xuan Wang, Director,Head of Anesthesiology, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03705780     History of Changes
Other Study ID Numbers: FTASOSSSOSP
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xuan Wang, Children's Hospital of Fudan University:
fentanyl
OSAS screening scale
adenotonsillectomy
diagnose

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics