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The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.
Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating >=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating <0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane >= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low concentration (LC) | Experimental | low concentration group |
|
| high concentration (HC) | Experimental | high concentration group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sevoflurane | Drug | extubation when end-tidal concentration of sevoflurane < 0.5% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Emergence Delirium (ED) | The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score >12. Higher score of PAED means a worse outcome. | within 30 minutes after awakening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuan Wang | Children's Hospital of Fudan University | Principal Investigator |
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Of 135 patients assessed for eligibility, 26 patients were excluded because they did not meet the inclusion criteria or declined to participate in the study.
From July 2015 to September 2015, 135 patients were assessed for eligibility in Children's Hospital of Fudan University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Concentration (LC) | low concentration group sevoflurane: extubation when end-tidal concentration of sevoflurane < 0.5%. |
| FG001 | High Concentration (HC) | high concentration group Sevoflurane: extubation when end-tidal concentration of sevoflurane >= 0.5%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Concentration (LC) | In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Emergence Delirium (ED) | The primary outcome was the number of participants with emergence delirium (ED) according to the peak PAED score measured by Pediatric Anesthesia Emergence Delirium Scale. All PAED (Pediatric Anesthesia Emergence Delirium scale) scores were assessed by a dedicated nurse who was blinded to the random assignment of patients to group. PAED scores were assessed on awakening (defined as reactive to verbal command or opening of eyes or crying in response to slight touch) and then every 5 minutes for 30 minutes. If the PAED score was ≥ 16, propofol 1 mg.kg-1 was administrated. After administration of propofol, PAED scores were no longer assessed. The peak (highest) PAED score for each patient was analyzed. ED was defined as a peak PAED score >12. Higher score of PAED means a worse outcome. | Posted | Count of Participants | Participants | within 30 minutes after awakening |
|
Adverse events were assessed and recorded during the PACU, an average of 1 hour.
In the PACU, any adverse events such as hypoxemia (defined as SpO2 <92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Concentration (LC) | In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| respiratory obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory obstruction was defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia. |
First, the patients might have experienced pain in the PACU. However, distinguishing ED from pain in the PACU could be difficult.
Second, we did not observe the duration of each case of ED.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xuan Wang | Children's Hospital of Fudan University | 021-18017591058 | 13818318679@139.com |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Sevoflurane |
| Drug |
extubation when end-tidal concentration of sevoflurane >= 0.5% |
|
| High Concentration (HC) |
In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | obtained from the hospital information system | Mean | Standard Deviation | kg |
|
In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%.
| OG001 | High Concentration (HC) | In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration. |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 3 |
| 39 |
| EG001 | High Concentration (HC) | In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration. | 0 | 53 | 0 | 53 | 5 | 53 |
|
| postoperative nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | defined as SpO2 <92% |
|
| laryngospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | defined as inability to ventilate despite maneuvers to relieve airway obstruction |
|
| bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | defined as wheezing on auscultation |
|
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |