Emergence DeliriumNCT04300374
Effects of Remifentanil Infusion on Emergence Delirium After Dental Surgery in Children
An observational study of Emergence Delirium, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All patients between 2 and 6 years old having American Society of Anesthesiologists score 1-2.
Who may be able to join
None listed.
Who cannot join
- neurological disease, psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Emergence Delirium
- Being tested
- The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperativelyOther
routine remifentanil infusion during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane only | inhalation of sevoflurane during general anesthesia Receives: Other: The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively | |
| Remifentanil and Sevoflurane | remifentanil infusion and inhalation of sevoflurane during general anesthesia Receives: Other: The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence delirium
incidence of emergence delirium
Measured: 30 minute after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Mar 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurcan Kutluer Karaca, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300374
- Sponsor's protocol ID
- Erzincan Universty
- Status last verified
- Jun 2020
- First submitted
- 8 Nov 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remifentanil Infusion on Emergence Delirium After Dental Surgery in Children
- ClinicalTrials.gov ID
- NCT04300374
- Acronym / sponsor ID
- Erzincan Universty
- Conditions
- Emergence Delirium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane only | – | Other: The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperativelyinhalation of sevoflurane during general anesthesia |
| Remifentanil and Sevoflurane | – | Other: The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperativelyremifentanil infusion and inhalation of sevoflurane during general anesthesia |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All patients between 2 and 6 years old having American Society of Anesthesiologists score 1-2.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- neurological disease, psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperativelyroutine remifentanil infusion during general anesthesia | Other | Remifentanil and Sevoflurane, Sevoflurane only |
Primary outcome
emergence delirium
Time frame: 30 minute after operation
incidence of emergence delirium
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Delirium, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emergence delirium (time frame: 30 minute after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.