Obesity, ChildhoodNCT04652193
The Effect of Obesity on Recovery Profile in Children
A study testing Recovery profile from general anesthesia in people with Obesity, Childhood, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Recovery profile from general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 15 Aug 2021
- Phase
- Interventional
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I and II
- Routine surgery under general anesthesia
Who cannot join
- Any known cerebrovascular disease
- Long- or short-term (within the previous 24 hours) intake of any drug acting in the central nervous system
- The patients bypassing the recovery room
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Medical Faculty Hospital
Konya, 42090
About this study
Official title: Does Obesity Effect the Recovery Profile in Children?
It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic discontinuation and LMA removal), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge will be also noted.
- Conditions
- Obesity, Childhood
- Being tested
- Recovery profile from general anesthesia
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery profile from general anesthesiaProcedure or surgery
It includes the phases during recovery from general anesthesia: Time to spontaneous ventilation, Laryngeal Mask Airway (LMA) removal time, open eyes, and Post-Anesthesia Care Unit (PACU) discharge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to spontaneous ventilation
The time between anesthetic discontinuation and beginning of spontaneous ventilation.
Measured: up to 20 minutes
LMA removal time
The time between anesthetic discontinuation and LMA removal.
Measured: up to 25 minutes
Time to open eyes
The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching
Measured: up to 30 minutes
PACU discharge time
The time between entering and leaving the PACU.
Measured: up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Jan 2021
- Primary completion1 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet SARGIN, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652193
- Sponsor's protocol ID
- 42001
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Obesity Effect the Recovery Profile in Children?
- ClinicalTrials.gov ID
- NCT04652193
- Acronym / sponsor ID
- 42001
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 3 Dec 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.
It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic discontinuation and LMA removal), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge will be also noted.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ASA physical status I and II
- Routine surgery under general anesthesia
Key exclusion criteria (3 listed)
- Any known cerebrovascular disease
- Long- or short-term (within the previous 24 hours) intake of any drug acting in the central nervous system
- The patients bypassing the recovery room
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 |
|---|---|---|
| Recovery profile from general anesthesiaIt includes the phases during recovery from general anesthesia: Time to spontaneous ventilation, Laryngeal Mask Airway (LMA) removal time, open eyes, and Post-Anesthesia Care Unit (PACU) discharge. | Procedure or surgery | – |
Primary outcome
Time to spontaneous ventilation
Time frame: up to 20 minutes
The time between anesthetic discontinuation and beginning of spontaneous ventilation.
LMA removal time
Time frame: up to 25 minutes
The time between anesthetic discontinuation and LMA removal.
Time to open eyes
Time frame: up to 30 minutes
The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching
PACU discharge time
Time frame: up to 45 minutes
The time between entering and leaving the PACU.
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 5 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Recovery profile from general anesthesia in people with Obesity, Childhood, run by Selcuk 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 2 inclusion and 3 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 5 Jul 2022. 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?
Time to spontaneous ventilation (time frame: up to 20 minutes). The study lists 4 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 5 Jul 2022.