PediatricNCT06218797
Nebulized Dexmedetomidine as a Premedication for Gastrointestinal Endoscopy in Pediatric Patients
A study testing a routine sedation protocol and Nebulized with dexmedetomidine in people with Pediatric and Sedation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort Read more about this study
- Who is it for?
- Ages 2 to 17 years
- What is being tested?
- a routine sedation protocol and Nebulized with dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2024to 30 Aug 2024
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I and II
- 2 to 17 years of age,
- Patient undergoing in Upper Gastrointestinal Endoscopy
Who cannot join
- Patients with heart disease
- Patients with mental-motor retardation
- Patients with abnormal upper respiratory tract
- Patients with a history of asthma
- Patients with upper respiratory tract history in the last 4 weeks
- Patients with severe sleep apnea on polysomnography
- ASA >III patients
- Patients with drug allergies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55139
About this study
Official title: Effect of Nebulized Dexmedetomidine on Gag Reflex Suppression in Pediatric Upper Gastrointestinal Endoscopy: a Randomized Controlled Trial
This study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort
Read the detailed description
Due to the intolerance of pediatric patients to the insertion of the endoscopic probe during upper gastrointestinal procedures, sedation and analgesia are required. In this patient group, the reflex to vomit is common during probe placement. Discomfort, pain, and hemodynamic changes can occur due to the vomiting reflex. In fact, this situation can lead to serious complications such as esophageal rupture. Inappropriate sedation conditions may result in increased post-procedural pain and agitation in patients.
Therefore, various sedative drugs are used for procedural sedation in pediatric patients. The use of these drugs during gastrointestinal endoscopy in the pediatric population can vary in terms of sedative, hemodynamic, respiratory, and side effects.
Dexmedetomidine, a highly selective alpha-2 agonist with central sedative and anxiolytic properties, has been tested in children for preoperative anxiolysis through nasal and inhalation routes. Due to its bioavailability of up to 82%, it is well absorbed systemically through oral and buccal routes.' It possesses sedative, analgesic, sympatholytic, and hemodynamic stability properties. Even at high doses, it has a unique feature of not causing respiratory depression, which gives it an advantage over other sedatives such as benzodiazepines, opioids, and propofol, all of which can cause dose-dependent respiratory depression. In this regard, it may be a good alternative for procedures like gastrointestinal endoscopy.
Based on these considerations, the investigators plan to conduct a randomized controlled study hypothesizing that nebulized dexmedetomidine as premedication in pediatric patients undergoing gastrointestinal endoscopy will significantly reduce the gag reflex.
108 patients will be included in the study. Patients will be divided into 2 groups.
- The control group (Group C)
- The group receiving nebulized dexmedetomidine (ND) (Group ND).
- Being tested
- a routine sedation protocol, Nebulized with dexmedetomidine
- Keywords
- Pediatric, Gastrointestinal endoscopy, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a routine sedation protocolOther
In this study group, a routine sedation protocol in our clinic will be applied in the endoscopic unit. Premedication will not be given to the patients.
Nebulized with dexmedetomidineDrug
Patients will be received nebulisation with dexmedetomidine 2mcg/kg 5 cc 20 minute prior to endoscopy. After that routine sedation protocol in our clinic will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Control group Receives: Other: a routine sedation protocol |
| Group ND | Active comparator | Nebulisation with dexmedetomidine Receives: Drug: Nebulized with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
gag reflex
This will be assessed when a vomiting like response will provoked upon introduction of the endoscope.
Measured: through endoscopic procedure up to one hour
Secondary outcomes (3)
Endoscopist's level of satisfaction with regard to the occurrence of gagging and the challenges encountered during the procedure
This will be assessed using an 5-point Likert scale
Measured: through endoscopic procedure up to one hour
Depth of sedation
This will be assessed by Ramsay sedation score
Measured: During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes)
Adverse effects
This will be reported for any adverse effects such as oxygen desaturation, the need for jaw thrust maneuver or manual ventilation, laryngospasm, vomiting, and shivering.
Measured: 2 hours post the procedure
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 start31 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Turunc, Ondokuz Mayıs University
- Investigators
- Esra Turunc, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218797
- Sponsor's protocol ID
- NDUGIE2023
- Status last verified
- Oct 2024
- First submitted
- 27 Dec 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turunc E, Ustun YB, Bilgin S, Kaya C, Koksal E, Dost B. Effect of nebulized dexmedetomidine on gag reflex suppression and sedation quality in pediatric patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2025 May 3;25(1):227. doi: 10.1186/s12871-025-03106-x.
PubMed 40319232
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Dexmedetomidine on Gag Reflex Suppression in Pediatric Upper Gastrointestinal Endoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06218797
- Acronym / sponsor ID
- NDUGIE2023
- Keywords
- Pediatric, Gastrointestinal endoscopy, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Aug 2024 (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.
This study aims to demonstrate that the application of nebulized dexmedetomidine to patients during pediatric upper gastrointestinal endoscopic procedures will significantly reduce the gag reflex and enhance both patient and practitioner comfort
Detailed description
Due to the intolerance of pediatric patients to the insertion of the endoscopic probe during upper gastrointestinal procedures, sedation and analgesia are required. In this patient group, the reflex to vomit is common during probe placement. Discomfort, pain, and hemodynamic changes can occur due to the vomiting reflex. In fact, this situation can lead to serious complications such as esophageal rupture. Inappropriate sedation conditions may result in increased post-procedural pain and agitation in patients.
Therefore, various sedative drugs are used for procedural sedation in pediatric patients. The use of these drugs during gastrointestinal endoscopy in the pediatric population can vary in terms of sedative, hemodynamic, respiratory, and side effects.
Dexmedetomidine, a highly selective alpha-2 agonist with central sedative and anxiolytic properties, has been tested in children for preoperative anxiolysis through nasal and inhalation routes. Due to its bioavailability of up to 82%, it is well absorbed systemically through oral and buccal routes.' It possesses sedative, analgesic, sympatholytic, and hemodynamic stability properties. Even at high doses, it has a unique feature of not causing respiratory depression, which gives it an advantage over other sedatives such as benzodiazepines, opioids, and propofol, all of which can cause dose-dependent respiratory depression. In this regard, it may be a good alternative for procedures like gastrointestinal endoscopy.
Based on these considerations, the investigators plan to conduct a randomized controlled study hypothesizing that nebulized dexmedetomidine as premedication in pediatric patients undergoing gastrointestinal endoscopy will significantly reduce the gag reflex.
108 patients will be included in the study. Patients will be divided into 2 groups.
- The control group (Group C)
- The group receiving nebulized dexmedetomidine (ND) (Group ND).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Other: a routine sedation protocolControl group |
| Group ND | Active comparator | Drug: Nebulized with dexmedetomidineNebulisation with dexmedetomidine |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I and II
- 2 to 17 years of age,
- Patient undergoing in Upper Gastrointestinal Endoscopy
Key exclusion criteria (8 listed)
- Patients with heart disease
- Patients with mental-motor retardation
- Patients with abnormal upper respiratory tract
- Patients with a history of asthma
- Patients with upper respiratory tract history in the last 4 weeks
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 |
|---|---|---|
| a routine sedation protocolIn this study group, a routine sedation protocol in our clinic will be applied in the endoscopic unit. Premedication will not be given to the patients. | Other | Group C |
| Nebulized with dexmedetomidinePatients will be received nebulisation with dexmedetomidine 2mcg/kg 5 cc 20 minute prior to endoscopy. After that routine sedation protocol in our clinic will be applied. | Drug | Group ND |
Primary outcome
gag reflex
Time frame: through endoscopic procedure up to one hour
This will be assessed when a vomiting like response will provoked upon introduction of the endoscope.
3 secondary outcomes
Endoscopist's level of satisfaction with regard to the occurrence of gagging and the challenges encountered during the procedure
Time frame: through endoscopic procedure up to one hour
Depth of sedation
Time frame: During Procedure (after 1 minute of induction of sedation and allover the time of the procedure every 2 or 3 minutes)
Adverse effects
Time frame: 2 hours post the procedure
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 22 Oct 2024.
- Derived from this study: PubMed 40319232Turunc E, Ustun YB, Bilgin S, Kaya C, Koksal E, Dost B. Effect of nebulized dexmedetomidine on gag reflex suppression and sedation quality in pediatric patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2025 May 3;25(1):227. doi: 10.1186/s12871-025-03106-x.
- 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.
Esra Turunc study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a routine sedation protocol and Nebulized with dexmedetomidine in people with Pediatric and Sedation, run by Ondokuz Mayıs 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 3 inclusion and 8 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 22 Oct 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?
gag reflex (time frame: through endoscopic procedure up to one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06218797, which also lists 1 linked publication.
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 22 Oct 2024.