Emergence DeliriumNCT06482125

Emergence Agitation Between Dexmedetomidine and Sevoflurane Anesthesia

A study testing Dexmedetomidine and Sevoflurane in people with Emergence Delirium, run by Pelita Harapan University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Emergence agitation is commonly encountered after receiving inhalation anesthesia. This distressing phenomenon carries risks that are harmful to patients, caregivers and medical personnel. Using total intravenous Dexmedetomidine, the investigators seek to reduce agitation and provide gentle emergence from anesthesia. Read more about this study

Who is it for?: Ages 3 months to 10 yearsHealthy volunteers can take part
Conditions the study is for: Emergence Delirium
What is being tested?: Dexmedetomidine and Sevoflurane
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteIndonesia
Study dates: 31 Jul 2024to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 months to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Patients with weight ranging 5 kg - 25 kg
Patients with American Society of Anesthesiologist (ASA) Physical Status Classification 1 and 2

Who cannot join

Patients with any acquired congenital syndrome
Patients who are actively taking anti-seizure medications and/or has been diagnosed with epilepsy
Patients with functional and structural abnormalities of the heart, including arrythmias
Patients with liver disease

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Pelita Harapan University
Tangerang, Banten, 15811

Other trials in Indonesia

About this study

Official title: Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial

Read the detailed description

Surgery for pediatric cleft lip and palate repair often utilizes high dose opioids and inhaled anaesthesia, thereby causing postoperative complications such as desaturation and/or severe agitation after anesthesia. These complications are detrimental to the child, medical personnel and causes tremendous psychologic stress to parents. This study aims to decrease these complications through Dexmedetomidine, an Alpha-2 receptor agonist with anxiolytic, sympatholytic and analgetic properties. Devoid of respiratory depressant effect, it allows patients to maintain effective ventilation and reduce agitation, postoperatively. Its unique anesthetic property may shed light to provide safe anesthesia and gentle emergence to this young, vulnerable population.

Conditions: Emergence Delirium
Being tested: Dexmedetomidine, Sevoflurane
Keywords: Emergence Agitation, Dexmedetomidine, Delirium, Children, Facial Cleft
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.

DexmedetomidineDrug
Also called Intravenous Dexmedetomidine
Intervention group will receive Total Intravenous Dexmedetomidine as their anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour continued as the sole anesthetic maintenance agent, thereafter.
SevofluraneDrug
Also called Inhalation Sevoflurane
Inhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.

Study groups in NCT06482125
Study group	Role	What they receive
Inhalation Sevoflurane	Active comparator	Participants in this group will receive inhalation anesthesia Sevoflurane at 2-3 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure. Receives: Drug: Sevoflurane
Total Intravenous Dexmedetomidine	Experimental	Participants in this group will receive Total Intravenous Dexmedetomidine as their sole anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour will be given throughout the surgical procedure. Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Emergence Agitation
Cravero scale uses a numeric scale. 1 = obtunded with no response to stimulation; 2 = asleep, but responsive to movement or stimuli; 3 = awake and responsive, 4 = crying; 5 = thrashing behavior that requires restraint. Minimum values of NOT AGITATED is 1.0 up to maximum of 2.9. Minimum values of AGITATED is 3.10 up to maximum of 5.0. Cravero scale is measured from the moment of extubation and every 15 minutes thereafter until the patient is completely awakened (in the recovery room). The total score is summed, and the average is reported.
Measured: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.
Duration of Anesthesia (Minutes)
Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent
Measured: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.
Duration of Surgery (Minutes)
Measures the time of surgery after the application of sterile draping up to the end of surgery.
Measured: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.

Secondary outcomes (2)

Time to Extubation (Minutes)
Measures the amount of time taken to extubate. Time is recorded from the moment Sevoflurane is stopped or Dexmedetomidine infusion is stopped until the patient is fit to extubated.
Measured: Maximum time to extubate was up to 26 minutes.
Time to Full Recovery
Measures amount of time taken to full awakening. Time is recorded from the moment of extubation until patient completely awaken at the recovery room area.
Measured: Maximum time observed was up to 105 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 202431 Dec 2024

First posted1 Jul 2024
Study start31 Jul 2024
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Pediatrics ages 3 months to 10 years
Masking: Single blind
Who is masked: Participant
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06482125
Sponsor's protocol ID: 183/K-LKJ/ETIK/V/2024
Status last verified: May 2025
First submitted: 25 Jun 2024
Last updated: 28 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data and other supporting information will be available upon request.

Publications

Liu D, Pan L, Gao Y, Liu J, Li F, Li X, Quan J, Huang C, Lian C. Efficaciousness of dexmedetomidine in children undergoing cleft lip and palate repair: a systematic review and meta-analysis. BMJ Open. 2021 Aug 16;11(8):e046798. doi: 10.1136/bmjopen-2020-046798.
PubMed 34400450
Peng W, Zhang T. Dexmedetomidine decreases the emergence agitation in infant patients undergoing cleft palate repair surgery after general anesthesia. BMC Anesthesiol. 2015 Oct 13;15:145. doi: 10.1186/s12871-015-0124-7.
PubMed 26464000

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability

All Emergence Delirium trials

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: Emergence Agitation in Pediatrics After Dexmedetomidine vs. Sevoflurane Anesthesia: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06482125
Acronym / sponsor ID: 183/K-LKJ/ETIK/V/2024
Conditions: Emergence Delirium
Keywords: Emergence Agitation, Dexmedetomidine, Delirium, Children, Facial Cleft
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Pelita Harapan UniversityUniversity, hospital or other
Study start: 31 Jul 2024 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 1 Jul 2024 (actual)
Results: Posted 28 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Pediatrics ages 3 months to 10 years

Arm	Type	Receives
Inhalation Sevoflurane	Active comparator	Drug: SevofluraneParticipants in this group will receive inhalation anesthesia Sevoflurane at 2-3 Vol% as their sole anesthetic maintenance agent throughout the surgical procedure.
Total Intravenous Dexmedetomidine	Experimental	Drug: DexmedetomidineParticipants in this group will receive Total Intravenous Dexmedetomidine as their sole anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour will be given throughout the surgical procedure.

Who may qualify

Ages: 3 months to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Patients with weight ranging 5 kg - 25 kg
Patients with American Society of Anesthesiologist (ASA) Physical Status Classification 1 and 2

Key exclusion criteria (4 listed)

Patients with any acquired congenital syndrome
Patients who are actively taking anti-seizure medications and/or has been diagnosed with epilepsy
Patients with functional and structural abnormalities of the heart, including arrythmias
Patients with liver disease

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
DexmedetomidineAlso: Intravenous DexmedetomidineIntervention group will receive Total Intravenous Dexmedetomidine as their anesthetic maintenance agent. Intravenous Dexmedetomidine 1.5ug/kg will be administered within 10 minutes and maintenance dose of 1.5ug/kg/hour continued as the sole anesthetic maintenance agent, thereafter.	Drug	Total Intravenous Dexmedetomidine
SevofluraneAlso: Inhalation SevofluraneInhalation Sevoflurane will be administered as an anesthetic maintenance agent. Sevoflurane at 2 - 3 Vol% will be administered throughout the operative procedure.	Drug	Inhalation Sevoflurane

Primary outcome

Emergence Agitation
Time frame: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.
Cravero scale uses a numeric scale. 1 = obtunded with no response to stimulation; 2 = asleep, but responsive to movement or stimuli; 3 = awake and responsive, 4 = crying; 5 = thrashing behavior that requires restraint. Minimum values of NOT AGITATED is 1.0 up to maximum of 2.9. Minimum values of AGITATED is 3.10 up to maximum of 5.0. Cravero scale is measured from the moment of extubation and every 15 minutes thereafter until the patient is completely awakened (in the recovery room). The total score is summed, and the average is reported.
Duration of Anesthesia (Minutes)
Time frame: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.
Measures the time of anesthesia (in minutes) starting from induction of anesthesia to the termination of anesthetic agent
Duration of Surgery (Minutes)
Time frame: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.
Measures the time of surgery after the application of sterile draping up to the end of surgery.

2 secondary outcomes

Time to Extubation (Minutes)
Time frame: Maximum time to extubate was up to 26 minutes.
Time to Full Recovery
Time frame: Maximum time observed was up to 105 minutes.

Results and safety

Results posted to the registry on 28 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Inhalation Sevoflurane	62	62
Total Intravenous Dexmedetomidine	59	59

Primary outcome: Emergence Agitation

Time frame: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.. Mean (Standard Deviation). Unit: Score on a scale

Measure	Inhalation Sevoflurane n = 62	Total Intravenous Dexmedetomidine n = 59
Value	3.9 (0.9)	2.5 (0.6)

Inhalation Sevoflurane vs Total Intravenous Dexmedetomidine: Odds Ratio (OR): 40.955 (95% CI 14.098 to 118.972), p = 0.001, Chi-squared, Corrected

Population analysed: Scale of 1.0 - 2.9 indicates no emergence agitation, a scale of 3.0 - 5.0 indicates emergence agitation

Primary outcome: Duration of Anesthesia (Minutes)

Time frame: From time of anesthesia induction up to the termination of anesthetic agent, assessed up to two hours.. Mean (Standard Deviation). Unit: minutes

Measure	Inhalation Sevoflurane n = 62	Total Intravenous Dexmedetomidine n = 59
Value	50 (17)	46 (15)

Inhalation Sevoflurane vs Total Intravenous Dexmedetomidine: p = 0.345, Wilcoxon (Mann-Whitney)

Primary outcome: Duration of Surgery (Minutes)

Time frame: From time of surgery up to the termination of anesthetic agent, assessed up to two hours.. Mean (Standard Deviation). Unit: minutes

Measure	Inhalation Sevoflurane n = 62	Total Intravenous Dexmedetomidine n = 59
Value	41 (15)	39 (14)

Inhalation Sevoflurane vs Total Intravenous Dexmedetomidine: p = 0.450, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inhalation Sevoflurane	0 of 62 (0%)	0 of 62 (0%)	0 of 62
Intravenous Dexmedetomidine	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 34400450Liu D, Pan L, Gao Y, Liu J, Li F, Li X, Quan J, Huang C, Lian C. Efficaciousness of dexmedetomidine in children undergoing cleft lip and palate repair: a systematic review and meta-analysis. BMJ Open. 2021 Aug 16;11(8):e046798. doi: 10.1136/bmjopen-2020-046798.
Results publication: PubMed 26464000Peng W, Zhang T. Dexmedetomidine decreases the emergence agitation in infant patients undergoing cleft palate repair surgery after general anesthesia. BMC Anesthesiol. 2015 Oct 13;15:145. doi: 10.1186/s12871-015-0124-7.
Individual participant dataSharing planned: Yes. Individual participant data and other supporting information will be available upon request.

Related trials for Emergence Delirium

RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability

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.

Hori Hariyanto, MD study director

Pelita Harapan 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 Dexmedetomidine and Sevoflurane in people with Emergence Delirium, run by Pelita Harapan 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 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. 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?

Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Emergence Agitation (time frame: Assessed starting the time of extubation and every 15 minutes interval until the patient is completely awake in the recovery room. The average of all values throughout the observation period was summed and the average scale reported.). The study lists 3 primary outcomes in all. 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 NCT06482125, which also lists 2 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 28 May 2025.