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The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium

The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium After Sevoflurane Anesthesia in Pediatric Strabismus Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108795
Enrollment
86
Registered
2014-04-09
Start date
2014-04-30
Completion date
2016-05-31
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Brief summary

The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.

Detailed description

Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.

Interventions

DRUGRemifentanil

Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)

DRUGPlacebo

Sponsors

Yeungnam University College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists physical status I and II * preschool-aged children undergoing strabismus surgery

Exclusion criteria

* psychological disorders * emotional disorders * abnormal cognitive development * developmental delay * allergy to the drugs in our protocol

Design outcomes

Primary

MeasureTime frameDescription
the scale of emergence agitationup to 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.A blinded observer record emergence agitation at just after laryngeal mask removal, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.

Secondary

MeasureTime frameDescription
the effect of remifentanil on the emergenceup to 30 minutes after the discharge form postanesthetic care unitA blinded observer record duration of anaesthesia, eye-opening time, time to remove laryngeal mask airway, respiratory depression, nausea, and vomiting at the end of surgery, 5 minutes after arrival in postanesthetic care unit, 10 minutes after arrival in postanesthetic care unit, 15 minutes after arrival in postanesthetic care unit, 30 minutes after arrival in postanesthetic care unit, and 30 minutes after discharge from postanesthetic care unit.

Countries

South Korea

Contacts

Primary ContactSangjin Park, M.D.
apsj0718@naver.com82-53-620-3366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026