Propofol for Treatment on Emergence Agitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02738814|
Recruitment Status : Unknown
Verified April 2016 by Sangjae Park, Korea University Anam Hospital.
Recruitment status was: Enrolling by invitation
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Child Anesthesia Morbidity||Drug: propofol||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Clinical Study on the Effects of Propofol for Treatment on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Strabismus Surgery|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
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.
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 Name: fresofol MCT 1%
No Intervention: PAED < 14
Caregivers must first try to reassure patients.
- Change of Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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.
- Duration of PACU stay [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738814
|Korea, Republic of|
|Korea University Medical Center, Anam hospital|
|Seoul, Seongbuk-gu, Korea, Republic of, 136-705|
|Study Director:||SeungZhoo Yoon, M.D.PhD.||Department of Anesthesiology and Pain medicine. Korea universicy medical center.|