Emergence DeliriumPhase 4NCT06761092
Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children
A Phase 4 study testing Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children and Nebulized 0.9% Normal Saline in people with Emergence Delirium and Delirium - Postoperative, run by Udayana University at 1 site in Indonesia.
Trial summary
Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia. 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, Delirium - Postoperative
- What is being tested?
- Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children and Nebulized 0.9% Normal Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Dec 2024to 13 Feb 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Pediatric patients aged 2 to 6 years old.
- Planned general anesthesia using inhalation sevoflurane with endotracheal tube techniques
- Parents agree to participate in the study
Who cannot join
- Pediatric patients with > ASA II.
- Difficult airway management.
- Emergency surgery.
- Congenital abnormalities of vital organs.
- Malnutrition
- history or diagnosed with mental or cognitive disorders.
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- History of upper respiratory infection within 2 weeks before the procedure.
- History of allergy to dexmedetomidine.
- Surgery duration estimation exceeding 180 minutes.
- Parents refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Anesthesiology and Intensive Therapy Udayana University
Denpasar, Bali
About this study
Official title: Nebulized Dexmedetomidine to Reduce Post-Anesthesia Delirium of Sevoflurane in Preschool Children Undergoing Elective Surgery
Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia.
Researchers will compare nebulized Dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if the drug can reduce post anesthesia delirium incidence.
Read the detailed description
participant will : Nebulized with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, is administered before the induction of anesthesia in the reception area.
After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) in the recovery room.
- Conditions
- Emergence Delirium, Delirium - Postoperative
- Being tested
- Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children, Nebulized 0.9% Normal Saline
- Keywords
- nebulized, dexmedetomidine, post anesthesia delirium, sevoflurane, preschool
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool ChildrenDrug
Nebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area.
After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room
Nebulized 0.9% Normal SalineProcedure or surgery
Nebulization with normal saline 0.9% 3 ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children | Active comparator | Nebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area.
After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room. Receives: Drug: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children |
| Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children | Placebo comparator | Nebulization with normal saline 0.9% 3ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room. Receives: Procedure: Nebulized 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduce post anesthesia delirium incidence
After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room.
Measured: 120 minutes (after extubation till discharge from recovery room)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start13 Dec 2024
- Primary completion7 Feb 2025 (estimated)
- Study completion13 Feb 2025 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pediatric preschool, age 2-6 years old, undergoing elective general surgery
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimmy Wongkar, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761092
- Sponsor's protocol ID
- DP.04.03/D.XVII.2.2.2/76407/24
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Dexmedetomidine to Reduce Post-Anesthesia Delirium of Sevoflurane in Preschool Children Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT06761092
- Acronym / sponsor ID
- DP.04.03/D.XVII.2.2.2/76407/24
- Conditions
- Emergence Delirium, Delirium - Postoperative
- Keywords
- nebulized, dexmedetomidine, post anesthesia delirium, sevoflurane, preschool
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 7 Feb 2025 (estimated)
- Study completion
- 13 Feb 2025 (estimated)
- First posted
- 7 Jan 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.
Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia.
Researchers will compare nebulized Dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if the drug can reduce post anesthesia delirium incidence.
Detailed description
participant will : Nebulized with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, is administered before the induction of anesthesia in the reception area.
After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) in the recovery room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pediatric preschool, age 2-6 years old, undergoing elective general surgery
| Arm | Type | Receives |
|---|---|---|
| Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children | Active comparator | Drug: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool ChildrenNebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room. |
| Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children | Placebo comparator | Procedure: Nebulized 0.9% Normal SalineNebulization with normal saline 0.9% 3ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) at 15, 30, 60, and 120 minutes post-surgery in the recovery room. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients aged 2 to 6 years old.
- Planned general anesthesia using inhalation sevoflurane with endotracheal tube techniques
- Parents agree to participate in the study
Key exclusion criteria (10 listed)
- Pediatric patients with > ASA II.
- Difficult airway management.
- Emergency surgery.
- Congenital abnormalities of vital organs.
- Malnutrition
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 |
|---|---|---|
| Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool ChildrenNebulization with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room | Drug | Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children |
| Nebulized 0.9% Normal SalineNebulization with normal saline 0.9% 3 ml, administered before the induction of anesthesia in the reception area. After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room | Procedure or surgery | Nebulized Normal Saline 0.9% for Post-Anesthesia Delirium in Preschool Children |
Primary outcome
reduce post anesthesia delirium incidence
Time frame: 120 minutes (after extubation till discharge from recovery room)
After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the PAED score at 15, 30, 60, and 120 minutes post-surgery in the recovery room.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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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 4 study testing Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children and Nebulized 0.9% Normal Saline in people with Emergence Delirium and Delirium - Postoperative, run by Udayana University 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
reduce post anesthesia delirium incidence (time frame: 120 minutes (after extubation till discharge from recovery room)). 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 22 Jan 2025.