Propofol for Treatment on Emergence Agitation

April 13, 2016 updated by: Sangjae Park, Korea University Anam Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, Korea, Republic of, 136-705
        • Korea University Medical Center, Anam hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From just after extubation until the discharge from PACU, assessed up to 2 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Anam Hospital

Investigators

  • Study Director: SeungZhoo Yoon, M.D.PhD., Department of Anesthesiology and Pain medicine. Korea universicy medical center.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED15301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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