Clinical trial NCT02738814: Propofol for Treatment on Emergence Agitation
Official title: Clinical Study on the Effects of Propofol for Treatment on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Child
Anesthesia Morbidity
Keywords: emergence agitation
emergence delirium
PAED scale
The Modified Aldrete Scoring System
treatment
pediatric
sevoflurane
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Emergent Adverse Events [Safety and Tolerability]
timeFrame: From just after extubation until the discharge from PACU, assessed up to 2 hours.
Secondary outcomes:
measure: Duration of PACU stay
timeFrame: From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center, Anam hospital
state: Seongbuk-gu
Study officials:
affiliation: Department of Anesthesiology and Pain medicine. Korea universicy medical center.
name: SeungZhoo Yoon, M.D.PhD.
role: STUDY_DIRECTOR
References:
citation: Xu GS, Yoon SZ, Choi YJ, Shin HW, Kim JH. Postoperative propofol bolus treatment did not affect recovery time in patients with emergence agitation after sevoflurane anesthesia in pediatric patients undergoing strabismus surgery: Prospective nonrandomized case-control study. Medicine (Baltimore). 2022 Jul 15;101(28):e29521. doi: 10.1097/MD.0000000000029521.