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

NCT ID: NCT03705780

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2018-11-09

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Keywords

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fentanyl OSAS screening scale adenotonsillectomy diagnose

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

the short OSAS scale

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

fentanyl test

Intervention Type 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

Interventions

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the short OSAS scale

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

Intervention Type OTHER

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xuan Wang

Director，Head of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuan Wang

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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FTASOSSSOSP

Identifier Type: -

Identifier Source: org_study_id