Effects of Remifentanil Infusion on Emergence Delirium After Dental Surgery in Children

June 2, 2020 updated by: Nurcan Kutluer Karaca, Erzincan University

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

80

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

      • Erzincan, Turkey
        • Nurcan Kutluer Karaca

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

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria American Society of Anesthesiologists score 1-2

-

Exclusion Criteria:

  • neurological disease, psychiatric illness

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sevoflurane only
inhalation of sevoflurane during general anesthesia
routine remifentanil infusion during general anesthesia
Remifentanil and Sevoflurane
remifentanil infusion and inhalation of sevoflurane during general anesthesia
routine remifentanil infusion during general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergence delirium
Time Frame: 30 minute after operation
incidence of emergence delirium
30 minute after operation

Collaborators and Investigators

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

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 (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

March 6, 2020

First Posted (ACTUAL)

March 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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