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Propofol for Treatment on Emergence Agitation

Primary Purpose

Child, Anesthesia Morbidity

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
propofol
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child focused on measuring emergence agitation, emergence delirium, PAED scale, The Modified Aldrete Scoring System, treatment, pediatric, sevoflurane

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University Medical Center, Anam hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PAED > 13

PAED < 14

Arm Description

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.

Caregivers must first try to reassure patients.

Outcomes

Primary Outcome Measures

Change of Emergent Adverse Events [Safety and Tolerability]
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
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.

Full Information

First Posted
March 1, 2016
Last Updated
April 13, 2016
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02738814
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Anesthesia Morbidity
Keywords
emergence agitation, emergence delirium, PAED scale, The Modified Aldrete Scoring System, treatment, pediatric, sevoflurane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAED > 13
Arm Type
Experimental
Arm Description
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.
Arm Title
PAED < 14
Arm Type
No Intervention
Arm Description
Caregivers must first try to reassure patients.
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
fresofol MCT 1%
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
From just after extubation until the discharge from PACU, assessed up to 2 hours.
Secondary Outcome Measure Information:
Title
Duration of PACU stay
Description
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.
Time Frame
From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeungZhoo Yoon, M.D.PhD.
Organizational Affiliation
Department of Anesthesiology and Pain medicine. Korea universicy medical center.
Official's Role
Study Director
Facility Information:
Facility Name
Korea University Medical Center, Anam hospital
City
Seoul
State/Province
Seongbuk-gu
ZIP/Postal Code
136-705
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35838993
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.
Results Reference
derived

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Propofol for Treatment on Emergence Agitation

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