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

Fudan University

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: the short OSAS scale; Diagnostic Test: fentanyl test

Study type: Interventional

Funder types: Other

Identifiers

NCT03705780

FTASOSSSOSP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

the short OSAS scale

Other group

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

Treatment:

Other: the short OSAS scale

fentanyl test

Experimental group

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

Treatment:

Diagnostic Test: fentanyl test