Propofol for Treatment on Emergence Agitation

NCT02738814 | Unknown Phase 4 DMC

• 1 other identifier: ED15301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Child; Anesthesia Morbidity

Keywords

emergence agitation; emergence delirium; PAED scale; The Modified Aldrete Scoring System; treatment; pediatric; sevoflurane

Outcome Measures

Primary Outcomes (1)

• 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.

  From just after extubation until the discharge from PACU, assessed up to 2 hours.

Secondary Outcomes (1)

• Duration of PACU stay

  From the arrival of the PACU to discharge from the PACU, assessed an average of 1hour

Study Arms (2)

PAED > 13

EXPERIMENTAL

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

PAED < 14

NO INTERVENTION

Caregivers must first try to reassure patients.

Interventions

propofol DRUG

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.

Also known as: fresofol MCT 1%

PAED > 13

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA (american society of anesthesiologists) physical status patients, aged 3-10yr, presenting for elective strabismus surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Medical Center, Anam hospital

Seoul, Seongbuk-gu, 136-705, South Korea

Location

Related Publications (1)

• 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.

  PMID: 35838993 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• SeungZhoo Yoon, M.D.PhD.

  Department of Anesthesiology and Pain medicine. Korea universicy medical center.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: April 14, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)