Emergence DeliriumPhase 4NCT04263844
Intranasal Dexmedetomidine Versus Intranasal Midazolam for Emergence Delirium Prevention
A Phase 4 study testing Intranasal dexmedetomidine and Intranasal Midazolam in people with Emergence Delirium, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Intranasal dexmedetomidine and Intranasal Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Jan 2019to 10 Oct 2019
- Phase
- Phase 4
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children undergoing ophthalmologic surgery with general anesthesia
- children aged 1 - 12 years old
- physical status ASA 1-2
- signing informed consent
Who cannot join
- children undergoing emergency surgery
- children with PICU nursing after surgery
- children with psychological and neurological condition
- children with allergic history to dexmedetomidine and midazolam
- children with history of malignant hyperthermia or family history of malignant hyperthermia
- children with possibility of difficult intubation and ventilation
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery
This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.
Read the detailed description
There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.
- Conditions
- Emergence Delirium
- Being tested
- Intranasal dexmedetomidine, Intranasal Midazolam
- Keywords
- emergence, delirium, dexmedetomidine, midazolam, pediatric
- Medical subject headings
- Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexmedetomidineDrug
subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction
Intranasal MidazolamDrug
subject will receive premedication with intranasal midazolam thirty minutes before induction
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | subject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction Receives: Drug: Intranasal dexmedetomidine |
| Midazolam | Active comparator | subject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction Receives: Drug: Intranasal Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of emergence delirium thirty minutes after surgery
PAED score was measured
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start10 Jan 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andi Ade Wijaya Ramlan, Universitas Indonesia
- Investigators
- Andi Ade W Ramlan, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263844
- Sponsor's protocol ID
- IndonesiaUAnes 051
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen MM, Cameron CB, Duncan PG. Pediatric anesthesia morbidity and mortality in the perioperative period. Anesth Analg. 1990 Feb;70(2):160-7. doi: 10.1213/00000539-199002000-00005.
PubMed 2301747Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.
PubMed 25535538Kim JH. Mechanism of emergence agitation induced by sevoflurane anesthesia. Korean J Anesthesiol. 2011 Feb;60(2):73-4. doi: 10.4097/kjae.2011.60.2.73. Epub 2011 Feb 25. No abstract available.
PubMed 21390159Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
PubMed 18372935Key KL, Rich C, DeCristofaro C, Collins S. Use of propofol and emergence agitation in children: a literature review. AANA J. 2010 Dec;78(6):468-73.
PubMed 21309294Lee CJ, Lee SE, Oh MK, Shin CM, Kim YJ, Choe YK, Cheong SH, Lee KM, Lee JH, Lim SH, Kim YH, Cho KR. The effect of propofol on emergence agitation in children receiving sevoflurane for adenotonsillectomy. Korean J Anesthesiol. 2010 Aug;59(2):75-81. doi: 10.4097/kjae.2010.59.2.75. Epub 2010 Aug 20.
PubMed 20740210
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Premedication Between Dexmedetomidine and Midazolam Intranasal for the Prevention of Emergence Delirium in Children Undergoing Ophthalmic Surgery
- ClinicalTrials.gov ID
- NCT04263844
- Acronym / sponsor ID
- IndonesiaUAnes 051
- Conditions
- Emergence Delirium
- Keywords
- emergence, delirium, dexmedetomidine, midazolam, pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 11 Feb 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.
This study is a double-blind clinical trial, in pediatric patients aged 1-12 years with physical status ASA (American Society of Anesthesiology) 1 and 2 who underwent eye surgery under general anesthesia using Sevoflurane inhalation agents, in investigator institution during February-May 2019.. There were 64 children obtained by consecutive sampling, who underwent eye surgery in investigator institution during February-May 2019. The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from Emergence Delirium (ED) events, recovery time, and post-premedication desaturation events. Data analysis using Chi Square test and Mann-Whitney test.
Detailed description
There were 64 children obtained by consecutive sampling, The subjects then grouped into dexmedetomidine group and midazolam group. Effectiveness was assessed from ED events, recovery time, and post-premedication desaturation events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Intranasal dexmedetomidinesubject will receive premedication with intranasal dexmedetomidine 1 mcg/kgBB thirty minutes before induction |
| Midazolam | Active comparator | Drug: Intranasal Midazolamsubject will receive premedication with intranasal midazolam 0,1 mg/kgBB thirty minutes before induction |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children undergoing ophthalmologic surgery with general anesthesia
- children aged 1 - 12 years old
- physical status ASA 1-2
- signing informed consent
Key exclusion criteria (6 listed)
- children undergoing emergency surgery
- children with PICU nursing after surgery
- children with psychological and neurological condition
- children with allergic history to dexmedetomidine and midazolam
- children with history of malignant hyperthermia or family history of malignant hyperthermia
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 dexmedetomidinesubject will receive premedication with intranasal dexmedetomidine thirty minutes before induction | Drug | Dexmedetomidine |
| Intranasal Midazolamsubject will receive premedication with intranasal midazolam thirty minutes before induction | Drug | Midazolam |
Primary outcome
incidence of emergence delirium thirty minutes after surgery
Time frame: 30 minutes
PAED score was measured
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 12 Feb 2020.
- Results publication: PubMed 2301747Cohen MM, Cameron CB, Duncan PG. Pediatric anesthesia morbidity and mortality in the perioperative period. Anesth Analg. 1990 Feb;70(2):160-7. doi: 10.1213/00000539-199002000-00005.
- Results publication: PubMed 25535538Mohkamkar M Bs, Farhoudi F Md, Alam-Sahebpour A Md, Mousavi SA Md, Khani S PhD, Shahmohammadi S BSc. Postanesthetic Emergence Agitation in Pediatric Patients under General Anesthesia. Iran J Pediatr. 2014 Apr;24(2):184-90.
- Results publication: PubMed 21390159Kim JH. Mechanism of emergence agitation induced by sevoflurane anesthesia. Korean J Anesthesiol. 2011 Feb;60(2):73-4. doi: 10.4097/kjae.2011.60.2.73. Epub 2011 Feb 25. No abstract available.
- Results publication: PubMed 18372935Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
- Results publication: PubMed 21309294Key KL, Rich C, DeCristofaro C, Collins S. Use of propofol and emergence agitation in children: a literature review. AANA J. 2010 Dec;78(6):468-73.
- Results publication: PubMed 20740210Lee CJ, Lee SE, Oh MK, Shin CM, Kim YJ, Choe YK, Cheong SH, Lee KM, Lee JH, Lim SH, Kim YH, Cho KR. The effect of propofol on emergence agitation in children receiving sevoflurane for adenotonsillectomy. Korean J Anesthesiol. 2010 Aug;59(2):75-81. doi: 10.4097/kjae.2010.59.2.75. Epub 2010 Aug 20.
- 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.
Andi Ade W Ramlan principal investigator
Universitas Indonesia
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 Intranasal dexmedetomidine and Intranasal Midazolam in people with Emergence Delirium, 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 4 inclusion and 6 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 12 Feb 2020. 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. 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?
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?
incidence of emergence delirium thirty minutes after surgery (time frame: 30 minutes). 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 NCT04263844, which also lists 6 linked publications.
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 12 Feb 2020.