Anesthesia Morbidity, Child
Conditions
Keywords
emergence agitation, emergence delirium, PAED scale, The Modified Aldrete Scoring System, treatment, pediatric, sevoflurane
Brief summary
This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery.
Detailed description
Sevoflurane with rapid anesthetic induction and emergence, hemodynamic stability, and nonirritating airway properties, has acquired widespread acceptance in children. However, sevoflurane has been reported to be associated with emergence agitation in children, with a reported incidence of up to 80%. In severe case, it cause injury to the child or to the surgical site and lead to the accidental removal of surgical dressings and intravenous catheters. In case of intense agitation with high risk of self-injury, pharmacologic intervention seems reasonable. Pharmacologic treatment of emergence agitation relies on the administration of IV sedative agents (IV midazolam 0.1 mg/kg12 or propofol 0.5 or 1 mg/kg) or opioid agents (IV fentanyl 1 or 2 mcg/kg). However, these treatments are empirical and were extrapolated from pharmacologic preventive studies performed at the end of surgery or from personal experience. To the investigators knowledge, there is no risk of recurrence of EA after a first episode. Consequently, EA is not per se a factor of increased duration of PACU (post-anaesthesia care unit ) stay, but sedative or opioid agents administered postoperatively to alleviate it might prolong this stay. Therefore, the investigators design a study to confirm statistically effect of propofol for treatment on emergence agitation after sevoflurane anesthesia in pediatric strabismus surgery through PAED scale. Furthermore duration of PACU stay is checked after propofol administration.
Interventions
DRUGpropofol
When severe emergence agitation(PAED \> 13) is occurred, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA (american society of anesthesiologists) physical status patients, aged 3-10yr, presenting for elective strabismus surgery.
Exclusion criteria
* Refusal by parents, neurologic disease, developmental delay, history of any previous surgery, American society of Anesthesiologists physical status score of III or IV, and airway disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Emergent Adverse Events [Safety and Tolerability] | From just after extubation until the discharge from PACU, assessed up to 2 hours. | After anesthetic emergence, investigator, nurse and attending anesthesiologist check the PAED scale every 5min, up to 2 hours until discharge from PACU. If checked PAED scale is 14 or more, attending anesthesiologist administers 1% propofol 0.8\ 1.0mg/kg(sedative dose). Then they check PAED scale every 5min after the arousal from sedative state until the discharge from PACU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of PACU stay | From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour | The investigator check the duration of PACU stay, defined as the interval from the time of arrival of PACU to the time of discharge from PACU, if sadisfacted to discharge criteria score(from Aldrete JA. J Clin Anesth 1995; 7:89-91), a score 9 or more is required for discharge. |
Countries
South Korea
Outcome results
None listed