Clinical Trials Directory

Trials / Completed

CompletedNCT03705780

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Children's Hospital of Fudan University · Academic / Other
Sex
All
Age
3 Years – 18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERthe short OSAS scaleParents fill in the short OSAS screening scale in preoperative interview,calculate score of the scale.
DIAGNOSTIC_TESTfentanyl testIn 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

Timeline

Start date
2018-06-21
Primary completion
2018-11-09
Completion
2018-11-09
First posted
2018-10-15
Last updated
2018-12-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03705780. Inclusion in this directory is not an endorsement.