Propofol for Treatment on Emergence Agitation

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02738814

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aimed to verify the effects of propofol for treatment on emergence agitation (EA) after sevoflurane anesthesia in pediatric strabismus surgery.

Condition or Disease	Intervention/Treatment	Phase
Child Anesthesia Morbidity	Drug: propofol	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Clinical Study on the Effects of Propofol for Treatment on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Strabismus Surgery

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PAED > 13 When severe emergence agitation(PAED is 14 or more) is occured, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.	Drug: propofol 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. Other Names: fresofol MCT 1%
No Intervention: PAED < 14 Caregivers must first try to reassure patients.

Arm

Intervention/Treatment

Experimental: PAED > 13

When severe emergence agitation(PAED is 14 or more) is occured, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.

Drug: propofol

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.

Other Names:

fresofol MCT 1%

No Intervention: PAED < 14

Caregivers must first try to reassure patients.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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