Delirium on Emergence
Conditions
Keywords
sevoflurane, emergence delirium, preschool
Brief summary
The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.
Detailed description
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.
Interventions
DRUGsevoflurane
extubation when end-tidal concentration of sevoflurane \< 0.5%
DRUGSevoflurane
extubation when end-tidal concentration of sevoflurane \>= 0.5%
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Age 2-7 years * ASA I - II * Estimated surgery time \< 2 hours * Sevoflurane induction and maintenance along with caudal block or Axillary Block
Exclusion criteria
* Craniofacial anomalies * Difficult exposure of the vocal cordS * Obesity * Asthma * Invalid caudal block or axillary block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Emergence Delirium (ED) | within 30 minutes after awakening | 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. |
Participant flow
Recruitment details
From July 2015 to September 2015, 135 patients were assessed for eligibility in Children's Hospital of Fudan University.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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%. | 39 |
| 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. | 53 |
| Total | 92 |
Baseline characteristics
| Characteristic | Low Concentration (LC) | High Concentration (HC) | Total |
|---|---|---|---|
| Age, Continuous | 3.4 years STANDARD_DEVIATION 1.4 | 3.9 years STANDARD_DEVIATION 1.5 | 3.7 years STANDARD_DEVIATION 1.5 |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 31 Participants | 43 Participants | 74 Participants |
| Weight | 18.2 kg STANDARD_DEVIATION 4.4 | 19.5 kg STANDARD_DEVIATION 4.9 | 18.9 kg STANDARD_DEVIATION 4.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 53 |
| other Total, other adverse events | 3 / 39 | 5 / 53 |
| serious Total, serious adverse events | 0 / 39 | 0 / 53 |
Outcome results
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.
Time frame: within 30 minutes after awakening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Concentration (LC) | Number of Participants With Emergence Delirium (ED) | 5 Participants |
| High Concentration (HC) | Number of Participants With Emergence Delirium (ED) | 23 Participants |
p-value: 0.00395% CI: [1.4, 8.1]Chi-squared