NCT04300374

Brief Summary

In this study, the investigators tried to show the effect of remifentanil on emergence delirium caused by sevoflurane used in general anesthesia.We planned a retrospective study. We formed two groups of 80 participants. One group included patients who were received remifentanil infusion during general anesthesia.The other group included patients who were received only sevoflurane inhalation anesthesia. The patients included in the study were evaluated for emergence delirium in the postoperative period be evaluating the past recorded informations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

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

March 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

November 8, 2019

Last Update Submit

June 2, 2020

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

  • emergence delirium

    incidence of emergence delirium

    30 minute after operation

Study Arms (2)

Sevoflurane only

inhalation of sevoflurane during general anesthesia

Other: The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively

Remifentanil and Sevoflurane

remifentanil infusion and inhalation of sevoflurane during general anesthesia

Other: The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively

Interventions

The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperativelyOTHER

routine remifentanil infusion during general anesthesia

Remifentanil and SevofluraneSevoflurane only

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All patients between 2 and 6 years old having American Society of Anesthesiologists score 1-2.

You may not qualify if:

  • neurological disease, psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nurcan Kutluer Karaca

Erzincan, Turkey (Türkiye)

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
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2019

First Posted

March 9, 2020

Study Start

March 1, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)