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Laryngeal mask airway(LMA) is now a widely accepted airway device in general anesthesia for children. LMA removal after operation is always practiced in post-anesthesia-care-unit(PACU). The removal timing depends on recovery of spontaneous respiration and wash-out of inhalation anesthetics. This study focuses on the optimization for LMA removal strategy. Moreover, this study also discusses the transitional criteria from PACU to the ward.
The study recruits 180 children aged under 6-year-old undergoing elective general anesthesia. Laryngeal mask is used in procedure. The children are carried into PACU to get monitored and removal the LMA. The children are randomized into 4 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| movement,high Aldrete score group (MH group) | LMA removal be conducted when the child's spontaneous respiratory recovers with body movement spontaneously, and the child be transited from PACU when Aldrete score reaches 9 |
| |
| movement,low Aldrete score group (ML group) | LMA removal be conducted when the child's spontaneous respiratory recovers with body movement spontaneously, and the child be transited from PACU when Aldrete score reaches 7 |
| |
| sedation,high Aldrete score group (SH group) | LMA removal be conducted when the child's spontaneous respiratory recovers but with no body movement, and the child be transited from PACU when Aldrete score reaches 9 |
| |
| sedation,low Aldrete score group (SL group) | LMA removal be conducted when the child's spontaneous respiratory recovers but with no body movement, and the child be transited from PACU when Aldrete score reaches 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA removal | Behavioral | the timing when conducting LMA removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| baseline heart rate | heart rate before induction | before induction |
| heart rate after induction | heart rate after induction | immediately after induction |
| heart rate in procedure | heart rate in procedure | in procedure |
| heart rate when transited into PACU | heart rate into PACU | immediately after transited into PACU (first measured data in PACU) |
| heart rate when transited out PACU | heart rate out PACU | before transited out of PACU (last measured data in PACU) |
| heart rate spontaneous respiratory | heart rate when spontaneous respiratory recovers | immediately after recovering spontaneous respiratory |
| heart rate effective spontaneous respiratory | heart rate when effective spontaneous respiratory recovers | immediately after effective spontaneous respiratory recovers |
| heart rate LMA removal | heart rate when LMA removed | immediately after LMA removed |
| Measure | Description | Time Frame |
|---|---|---|
| parents' satisfaction score | questionnaire scored from 1-5 to assess the parents' satisfaction : score 1 for worst satisfied, score 5 for best satisfied | up to 3 days after surgery |
| sleep quality score |
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Inclusion Criteria:
Exclusion Criteria:
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children
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| Name | Affiliation | Role |
|---|---|---|
| Wenxian Li | Eye and ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye and EENT hospital of Fudan University | Shanghai | Shanghai Municipality | 021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38842951 | Derived | Tan F, Lu W, Li S, Chen J. Discharge Under Sedated Status can Decrease Postoperative Emergence Agitation in Pediatric Patients Undergoing Strabismus Surgery: A Prospective Randomized Controlled Trial. J Perianesth Nurs. 2024 Dec;39(6):985-989. doi: 10.1016/j.jopan.2024.01.014. Epub 2024 Jun 4. |
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| baseline mean blood pressure | mean blood pressure before induction | before induction |
| mean blood pressure after induction | mean blood pressure after induction | immediately after induction |
| mean blood pressure in procedure | mean blood pressure in procedure | in procedure |
| mean blood pressure when transited into PACU | mean blood pressure into PACU | immediately after transited into PACU (first measured data in PACU) |
| mean blood pressure when transited out PACU | mean blood pressure out PACU | before transited out of PACU (last measured data in PACU) |
| mean blood pressure spontaneous respiratory | mean blood pressure when spontaneous respiratory recovers | immediately after recovering spontaneous respiratory |
| mean blood pressure spontaneous respiratory | mean blood pressure when effective spontaneous respiratory recovers | immediately after effective spontaneous respiratory recovers |
| mean blood pressure LMA removal | mean blood pressure when effective spontaneous respiratory recovers | immediately after LMA removed |
| time length of LMA removal | time length from the child transited into PACU to LMA removal | from the time point of the child be transited into PACU until the time point of the LMA be removed |
| dwell time length in PACU | time length of the child staying in PACU | from the time point of the child be transited into PACU until the time point of the child be transited out of PACU |
| cough | cough count and severity | from the time point of the LMA be removed until the time point of the child be transited out of PACU |
| desaturation | desaturation count and severity | from the time point of the LMA be removed until the time point of the child be transited out of PACU |
| clenching | clenching during LMA removal | from the time point of the LMA be removed until the time point of the child be transited out of PACU |
| gross body movement | gross body movement during LMA removal | from the time point of the LMA be removed until the time point of the child be transited out of PACU |
| breath holding | breath holding during LMA removal | from the time point of the LMA be removed until the time point of the child be transited out of PACU |
| airway obstruction | airway obstruction | from the time point of the LMA be removed until the time point of the child be transited out of PACU |
questionnaire scored from 1-5 to assess the children's sleep quality : score 1 for worst sleep quality, score 5 for best sleep quality
| up to 3 days after surgery |
| FLACC(face,legs,activity,cry,consolability) scale score | FLACC scale scored from 0-10 to assess the children's pain after surgery: score 0 for no pain, score 10 for worst pain | up to 3 days after surgery |
| anxiety score | questionnaire scored from 1-5 to assess the parents' anxiety : score 1 for no anxiety, score 5 for worst anxiety | up to 3 days after surgery |