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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the short OSAS scale
fentanyl test
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring fentanyl, OSAS screening scale, adenotonsillectomy, diagnose

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chilren's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

the short OSAS scale

fentanyl test

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

hydromorphone requirement in PACU
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

Full Information

First Posted
September 25, 2018
Last Updated
December 11, 2018
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03705780
Brief Title
Fentanyl Test and A Short OSAS Screening Scale for Severe Obstructive Sleep Apnea
Official Title
Comparison of Preoperative Fentanyl Test and A Short OSAS Screening Scale for Identifying Severe Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
fentanyl, OSAS screening scale, adenotonsillectomy, diagnose

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the short OSAS scale
Arm Type
Other
Arm Description
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
Arm Title
fentanyl test
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
the short OSAS scale
Intervention Description
Parents fill in the short OSAS screening scale in preoperative interview,calculate score of the scale.
Intervention Type
Diagnostic Test
Intervention Name(s)
fentanyl test
Intervention Description
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 Measure Information:
Title
Sensitivity, specificity ,positive predictive value and negative predictive value,likelihood ratio
Description
Compared the diagnostic results of fentanyl test and the short OSAS screening scale with the diagnostic results of golden standard PSG.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
hydromorphone requirement in PACU
Description
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
Time Frame
50 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan Wang
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chilren's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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