Sedative OverdoseNCT06218173
Local Anesthesia Impact on Dental Sedation
An observational study of Sedative Overdose, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures. The main questions it aims to answer are: Impact of local anesthesia on sedation depth and hemodynamic parameters Impact of presence of local anesthesia on the requirement of… Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Sedative Overdose
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 30 Dec 2022
- 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 8 years
- All sexes
- Child
Study population: ASA I-II pediatric patients who were deeply sedated for dental restorations in a tertiary university hospital.
Who may be able to join
- Paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. Patients with an American Society of Anesthesiologist (ASA) physical status classification of I-II and aged between 2 and 8 years were included in the study.
Who cannot join
- Exclusion criteria were ASA status III-V, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, 06560
About this study
Official title: Clinical Impact of Local Anaesthetic Timing on Sedation Stability and Propofol Dosage in Paediatric Dental Sedation
The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures.
The main questions it aims to answer are:
- Impact of local anesthesia on sedation depth and hemodynamic parameters
- Impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation.
Participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued.
If there is a comparison group:
Read the detailed description
Local anaesthesia (LA) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of LA administration during sedation is varies according to personal preferences of dentists. Aim of this retrospective study is to investigate the effects of the timing of LA on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures.
Records of healthy children who were sedated for dental restorations will be divided into two groups. Patients who received LA at the beginning of sedation or who received LA at the end of sedation after completion of restorations. It is planned to compare the patient groups in terms of demographic data, hemodynamic data, BIS scores, Ramsey Sedation Scale scores, total propofol dose administered.
- Conditions
- Sedative Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early LA group | The group that received LA at the induction of the sedation | |
| Late LA group | The group that received LA at the end of the sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the effect of local anesthesia on sedation depth
Measured: 1 year
Estimate the effect of local anesthesia on hemodynamic parameters
Measured: 1 year
Estimate the effect of local anesthesia on total propofol requirement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative OverdoseStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagil Vural, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218173
- Sponsor's protocol ID
- 36290600/55
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Local Anaesthetic Timing on Sedation Stability and Propofol Dosage in Paediatric Dental Sedation
- ClinicalTrials.gov ID
- NCT06218173
- Acronym / sponsor ID
- 36290600/55
- Conditions
- Sedative Overdose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 23 Jan 2024 (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.
The goal of this observational study is to investigate the impact of local anesthesia in health children who were sedated for dental procedures.
The main questions it aims to answer are:
- Impact of local anesthesia on sedation depth and hemodynamic parameters
- Impact of presence of local anesthesia on the requirement of propofol to maintain deep sedation.
Participants were deeply sedated and one group received local anesthesia at the anesthesia induction, while other group of patients received local anesthesia after the maintenance anesthesia was discontinued.
If there is a comparison group:
Detailed description
Local anaesthesia (LA) is often preferred for stabilization of vital signs, depth of anaesthesia in dental restorations but the optimal timing of LA administration during sedation is varies according to personal preferences of dentists. Aim of this retrospective study is to investigate the effects of the timing of LA on hemodynamic parameters, depth of anaesthesia and total dose of anaesthetic drugs given in paediatric patients sedated for dental procedures.
Records of healthy children who were sedated for dental restorations will be divided into two groups. Patients who received LA at the beginning of sedation or who received LA at the end of sedation after completion of restorations. It is planned to compare the patient groups in terms of demographic data, hemodynamic data, BIS scores, Ramsey Sedation Scale scores, total propofol dose administered.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early LA group | – | –The group that received LA at the induction of the sedation |
| Late LA group | – | –The group that received LA at the end of the sedation |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- ASA I-II pediatric patients who were deeply sedated for dental restorations in a tertiary university hospital.
Key inclusion criteria (1 listed)
- Paediatric dental patients who were previously sedated and fulfilled the following inclusion criteria were included in this investigation. Patients with an American Society of Anesthesiologist (ASA) physical status classification of I-II and aged between 2 and 8 years were included in the study.
Key exclusion criteria (1 listed)
- Exclusion criteria were ASA status III-V, age older than 8 years, having any history of allergy to anaesthetic drugs and renal disease interfering with drug metabolism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimate the effect of local anesthesia on sedation depth
Time frame: 1 year
Estimate the effect of local anesthesia on hemodynamic parameters
Time frame: 1 year
Estimate the effect of local anesthesia on total propofol requirement
Time frame: 1 year
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 23 Jan 2024.
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 Sedative Overdose, run by Ankara 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 1 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 23 Jan 2024. 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?
Estimate the effect of local anesthesia on sedation depth (time frame: 1 year). The study lists 3 primary outcomes in all. 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 23 Jan 2024.