Elective Surgical ProcedurePhase 3NCT06991647
Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation
A Phase 3 study testing Intranasal dexmedetomidine and 0.9% NaCl solution in people with Elective Surgical Procedure and ASA Physical Status I, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this study is to find out if a medicine called dexmedetomidine, given as a nasal spray, can help patients stay calm and comfortable before having a breathing tube placed (intubation). Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Elective Surgical Procedure, ASA Physical Status I, ASA Physical Status II
- What is being tested?
- Intranasal dexmedetomidine and 0.9% NaCl solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Oct 2024to 10 Jan 2025
- Phase
- Phase 3
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1-6 years undergoing elective surgery
- ASA physical status 1 and 2
Who cannot join
- Children with difficult airway
- Active infection in nasal and oral area
- Subjects with mental retardation, ADHD, and cerebral palsy
- Difficult intravenous access
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta, Jakarta Special Capital Region, 10430
About this study
Official title: Effectiveness of Adjuvant Premedication of Intranasal Dexmedetomidine on the Intubation Procedure in Children
The purpose of this study is to find out if a medicine called dexmedetomidine, given as a nasal spray, can help patients stay calm and comfortable before having a breathing tube placed (intubation). Researchers want to see if using this nasal spray affects blood pressure, heart rate, comfort with the oxygen mask, how quickly the tube is placed, and how sleepy patients become. They also want to check if patients who receive dexmedetomidine need less pain medicine (Fentanyl) during the procedure. Participants will receive either the dexmedetomidine nasal spray or a plain saltwater spray (placebo). Doctors will then measure blood pressure, heart rate, comfort levels, time needed for intubation, sleepiness, and the amount of pain medication used.
- Being tested
- Intranasal dexmedetomidine, 0.9% NaCl solution
- Keywords
- intranasal dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
Intranasal dexmedetomidine at a dose of 2 mcg/kg body weight, diluted in 1 mL of 0.9% NaCl, administered using a 1 mL syringe connected to a Teleflex MAD Nasal device while in the supine position. The soft tip of the device will be gently placed into each nostril without applying pressure. The solution will be sprayed slowly to create a fine mist. The total dose will be divided equally, with 0.5 mL delivered into each nostril, administered approximately 30 minutes before intubation during induction.
0.9% NaCl solutionDrug
Participants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a Teleflex MAD nasal device while in the supine position. The soft tip of the Teleflex MAD nasal device is gently placed into each nostril without applying pressure. The solution is slowly sprayed to create a fine mist for patient comfort. The dose is divided equally, delivering 0.5 ml into each nostril, approximately 30 minutes before intubation during induction.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a nasal device. Receives: Drug: 0.9% NaCl solution |
| Intranasal dexmedetomidine | Experimental | Participants will receive intranasal dexmedetomidine at a dose of 2 mcg/kg body weight, diluted in 1 mL of 0.9% NaCl, administered using a 1 mL syringe connected to a nasal device. Receives: Drug: Intranasal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure
Measured by non-invasive blood pressure monitoring
Measured: immediately before premedication and immediately after intubation
Heart rate
Measured by electrocardiography electrodes in vital sign monitor
Measured: immediately before premedication and immediately after intubation
Mask acceptance
Measured using the Pediatric Anesthesia Behavior (PAB) scale. The PAB scale range from 1 to 3, with 1 indicating the best outcome (happy) and 3 the worst outcome (mad).
Measured: Before induction
Intubation duration
Measured using stopwatch, in seconds Started when inserting laryngoscope into the mouth, ended when end tidal CO2 is detected by the monitor
Measured: during intubation
Sedation Score
Sedation level was assessed using the COMFORT Behaviour Scale, which evaluates the child's sedation state after administration of dexmedetomidine. The total score ranges from 6 to 30, with the following interpretations:
- Excessive sedation: 6-10
- Adequate sedation: 11-22
- Inadequate sedation: 23-30 Higher scores indicate less effective sedation control, whereas lower scores reflect deeper sedation.
Measured: Immediately upon arrival to the operating room, before induction of anesthesia
Opioid use
Amount of fentanyl (per kg body weight) used during intubation
Measured: Immediately after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start28 Oct 2024
- Primary completion28 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raihanita Zahra, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991647
- Sponsor's protocol ID
- 24-09-1444
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adjuvant Premedication of Intranasal Dexmedetomidine on the Intubation Procedure in Children
- ClinicalTrials.gov ID
- NCT06991647
- Acronym / sponsor ID
- 24-09-1444
- Keywords
- intranasal dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 28 May 2025 (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 purpose of this study is to find out if a medicine called dexmedetomidine, given as a nasal spray, can help patients stay calm and comfortable before having a breathing tube placed (intubation). Researchers want to see if using this nasal spray affects blood pressure, heart rate, comfort with the oxygen mask, how quickly the tube is placed, and how sleepy patients become. They also want to check if patients who receive dexmedetomidine need less pain medicine (Fentanyl) during the procedure. Participants will receive either the dexmedetomidine nasal spray or a plain saltwater spray (placebo). Doctors will then measure blood pressure, heart rate, comfort levels, time needed for intubation, sleepiness, and the amount of pain medication used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0.9% NaCl solutionParticipants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a nasal device. |
| Intranasal dexmedetomidine | Experimental | Drug: Intranasal dexmedetomidineParticipants will receive intranasal dexmedetomidine at a dose of 2 mcg/kg body weight, diluted in 1 mL of 0.9% NaCl, administered using a 1 mL syringe connected to a nasal device. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 1-6 years undergoing elective surgery
- ASA physical status 1 and 2
Key exclusion criteria (4 listed)
- Children with difficult airway
- Active infection in nasal and oral area
- Subjects with mental retardation, ADHD, and cerebral palsy
- Difficult intravenous access
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 |
|---|---|---|
| Intranasal dexmedetomidineIntranasal dexmedetomidine at a dose of 2 mcg/kg body weight, diluted in 1 mL of 0.9% NaCl, administered using a 1 mL syringe connected to a Teleflex MAD Nasal device while in the supine position. The soft tip of the device will be gently placed into each nostril without applying pressure. The solution will be sprayed slowly to create a fine mist. The total dose will be divided equally, with 0.5 mL delivered into each nostril, administered approximately 30 minutes before intubation during induction. | Drug | Intranasal dexmedetomidine |
| 0.9% NaCl solutionParticipants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a Teleflex MAD nasal device while in the supine position. The soft tip of the Teleflex MAD nasal device is gently placed into each nostril without applying pressure. The solution is slowly sprayed to create a fine mist for patient comfort. The dose is divided equally, delivering 0.5 ml into each nostril, approximately 30 minutes before intubation during induction. | Drug | Placebo |
Primary outcome
Mean arterial pressure
Time frame: immediately before premedication and immediately after intubation
Measured by non-invasive blood pressure monitoring
Heart rate
Time frame: immediately before premedication and immediately after intubation
Measured by electrocardiography electrodes in vital sign monitor
Mask acceptance
Time frame: Before induction
Measured using the Pediatric Anesthesia Behavior (PAB) scale. The PAB scale range from 1 to 3, with 1 indicating the best outcome (happy) and 3 the worst outcome (mad).
Intubation duration
Time frame: during intubation
Measured using stopwatch, in seconds Started when inserting laryngoscope into the mouth, ended when end tidal CO2 is detected by the monitor
Sedation Score
Time frame: Immediately upon arrival to the operating room, before induction of anesthesia
Sedation level was assessed using the COMFORT Behaviour Scale, which evaluates the child's sedation state after administration of dexmedetomidine. The total score ranges from 6 to 30, with the following interpretations: * Excessive sedation: 6-10 * Adequate sedation: 11-22 * Inadequate sedation: 23-30 Higher scores indicate less effective sedation control, whereas lower scores reflect deeper sedation.
Opioid use
Time frame: Immediately after intubation
Amount of fentanyl (per kg body weight) used during intubation
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 28 May 2025.
- 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?
A Phase 3 study testing Intranasal dexmedetomidine and 0.9% NaCl solution in people with Elective Surgical Procedure and ASA Physical Status I, run by Universitas Indonesia at 1 site in Indonesia.
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 4 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 28 May 2025. 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 Indonesia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean arterial pressure (time frame: immediately before premedication and immediately after intubation). The study lists 6 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 28 May 2025.