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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705780
• Other study ID #: FTASOSSSOSP
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: November 9, 2018

Study information

• Verified date: October 2018
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

1. The American society of anesthesiologists (ASA) class ? ~ ?

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

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

Locations

Country	Name	City	State
China	Chilren's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	50 minutes after extubation