NCT02509221

Brief Summary

Emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with Sevoflurane. Restless recovery from anesthesia may not only cause injury to the child or to the surgical site, but may also lead to the accidental removal of surgical dressings, IV catheters, and drains. is one of the The purpose of the study is to find whether duration of exposure to Sevoflurane has any effect on the incidence of Emergence Delirium.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 23, 2015

Last Update Submit

August 24, 2023

Conditions

Delirium on Emergence

Outcome Measures

Primary Outcomes (2)

  • Incidence of emergence delirium

    using the PAED scale

    30 mintes after anesthesia

  • Severity of emergence delirium

    using the PAED scale

    30 minutes after anesthesia

Study Arms (3)

Less than 30 minutes

30-60 minutes

More than 60 minutes

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients between 1-6 years old receiving anesthesia for non-surgical reasons

You may qualify if:

  • age between 1-6 years of age
  • receiving general anesthesia for non-surgical procedure

You may not qualify if:

  • history of emergence delirium
  • severe CNS disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 23, 2015

First Posted

July 27, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

US(1)