Emergence AgitationNCT06218680
Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan
A study testing Propofol and Normal saline in people with Emergence Agitation, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Propofol and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteThailand
- Study dates
- 20 Jan 2024to 30 Apr 2025
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-8 years
- ASA class I or II ,who schedule for MRI scan under sevoflurane anesthesia
Who cannot join
- Developmental delay
- Psychological and neurological disorders
- Abnormal airway
- Reactive airway disease
- Allergy to propofol, egg product
- Family history of malignant hyperthermia
- Need iv sedative medication before induction
- Obesity
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Khon kaen University
Khon Kaen, Muang, 40002
Santhita Pimonbut, M.D., santhita.p@kkumail.com
Chakthip Suttinarakorn, M.D.
About this study
The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. The main question it aims to answer is "Can low dose propofol reduce the incidence of emergence agitation after general anesthesia?" Participants will be given propofol 0.5 mg/kg or saline according to the allocated group at the completion of MRI scan
- Conditions
- Emergence Agitation
- Being tested
- Propofol, Normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia
Normal salineDrug
recieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia
| Study group | Role | What they receive |
|---|---|---|
| group P | Experimental | Receive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia Receives: Drug: Propofol |
| group S | Placebo comparator | Receive saline intravenously at end of sevoflurane anesthesia Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of emergence agitation
Measured: at 5,10,15,20,25,30 minutes after extubation
Secondary outcomes (4)
Incidence of complication
Nausea or vomiting, airway obstruction, laryngospasm, desaturation and apnea
Measured: 2 hours after extubation
Use of rescue medication
use of ondansetron, atropine
Measured: 2 hours after extubation
Emergence time
duration of emergence
Measured: 2 hours after extubation
Length of stay in post anesthetic care unit
Measured: 2 hours after extubation
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 start20 Jan 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies 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
- RCT
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santhita Pimonbut, Khon Kaen University
- Investigators
- Santhita Pimonbut, M.D., Principal investigator, department of anesthesiology, faculty of medicine, Khonkaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218680
- Sponsor's protocol ID
- HE661348
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected individual participant data
Publications
Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
PubMed 11473855Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005.
PubMed 8895263Aouad MT, Yazbeck-Karam VG, Nasr VG, El-Khatib MF, Kanazi GE, Bleik JH. A single dose of propofol at the end of surgery for the prevention of emergence agitation in children undergoing strabismus surgery during sevoflurane anesthesia. Anesthesiology. 2007 Nov;107(5):733-8. doi: 10.1097/01.anes.0000287009.46896.a7.
PubMed 18073548Cravero JP, Beach M, Thyr B, Whalen K. The effect of small dose fentanyl on the emergence characteristics of pediatric patients after sevoflurane anesthesia without surgery. Anesth Analg. 2003 Aug;97(2):364-367. doi: 10.1213/01.ANE.0000070227.78670.43.
PubMed 12873918Costi D, Ellwood J, Wallace A, Ahmed S, Waring L, Cyna A. Transition to propofol after sevoflurane anesthesia to prevent emergence agitation: a randomized controlled trial. Paediatr Anaesth. 2015 May;25(5):517-23. doi: 10.1111/pan.12617. Epub 2015 Jan 13.
PubMed 25586124Ramlan AAW, Pardede DKB, Marsaban AHMS, Hidayat J, Peddyandhari FS. Efficacy of 0.5 mg/kg of propofol at the end of anesthesia to reduce the incidence of emergence agitation in children undergoing general anesthesia with sevoflurane. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):177-181. doi: 10.4103/joacp.JOACP_257_19. Epub 2020 Jun 15.
PubMed 33013031Abu-Shahwan I. Effect of propofol on emergence behavior in children after sevoflurane general anesthesia. Paediatr Anaesth. 2008 Jan;18(1):55-9. doi: 10.1111/j.1460-9592.2007.02376.x.
PubMed 18095967Ruenhunsa T, Pimonbut S, Sangsungnern P, Wittayapairoch P, Sripadungkul D, Wongsaneha N, Sorit W, Narrutto P. Effect of Low-Dose Propofol Administered at the End of Sevoflurane Anesthesia on Emergence Agitation in Pediatric Patients Undergoing MRI: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Sep 1;2026:6532790. doi: 10.1155/anrp/6532790. eCollection 2026.
PubMed 42688410
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan
- ClinicalTrials.gov ID
- NCT06218680
- Acronym / sponsor ID
- HE661348
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- 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.
The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. The main question it aims to answer is "Can low dose propofol reduce the incidence of emergence agitation after general anesthesia?" Participants will be given propofol 0.5 mg/kg or saline according to the allocated group at the completion of MRI scan
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| group P | Experimental | Drug: PropofolReceive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia |
| group S | Placebo comparator | Drug: Normal salineReceive saline intravenously at end of sevoflurane anesthesia |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 2-8 years
- ASA class I or II ,who schedule for MRI scan under sevoflurane anesthesia
Key exclusion criteria (8 listed)
- Developmental delay
- Psychological and neurological disorders
- Abnormal airway
- Reactive airway disease
- Allergy to propofol, egg product
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 |
|---|---|---|
| Propofolrecieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia | Drug | group P |
| Normal salinerecieve propofol 0.5 mg/kg intravenously at end of sevoflurane anesthesia | Drug | group S |
Primary outcome
incidence of emergence agitation
Time frame: at 5,10,15,20,25,30 minutes after extubation
4 secondary outcomes
Incidence of complication
Time frame: 2 hours after extubation
Use of rescue medication
Time frame: 2 hours after extubation
Emergence time
Time frame: 2 hours after extubation
Length of stay in post anesthetic care unit
Time frame: 2 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 11473855Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
- Background: PubMed 8895263Welborn LG, Hannallah RS, Norden JM, Ruttimann UE, Callan CM. Comparison of emergence and recovery characteristics of sevoflurane, desflurane, and halothane in pediatric ambulatory patients. Anesth Analg. 1996 Nov;83(5):917-20. doi: 10.1097/00000539-199611000-00005.
- Background: PubMed 18073548Aouad MT, Yazbeck-Karam VG, Nasr VG, El-Khatib MF, Kanazi GE, Bleik JH. A single dose of propofol at the end of surgery for the prevention of emergence agitation in children undergoing strabismus surgery during sevoflurane anesthesia. Anesthesiology. 2007 Nov;107(5):733-8. doi: 10.1097/01.anes.0000287009.46896.a7.
- Background: PubMed 12873918Cravero JP, Beach M, Thyr B, Whalen K. The effect of small dose fentanyl on the emergence characteristics of pediatric patients after sevoflurane anesthesia without surgery. Anesth Analg. 2003 Aug;97(2):364-367. doi: 10.1213/01.ANE.0000070227.78670.43.
- Background: PubMed 25586124Costi D, Ellwood J, Wallace A, Ahmed S, Waring L, Cyna A. Transition to propofol after sevoflurane anesthesia to prevent emergence agitation: a randomized controlled trial. Paediatr Anaesth. 2015 May;25(5):517-23. doi: 10.1111/pan.12617. Epub 2015 Jan 13.
- Background: PubMed 33013031Ramlan AAW, Pardede DKB, Marsaban AHMS, Hidayat J, Peddyandhari FS. Efficacy of 0.5 mg/kg of propofol at the end of anesthesia to reduce the incidence of emergence agitation in children undergoing general anesthesia with sevoflurane. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):177-181. doi: 10.4103/joacp.JOACP_257_19. Epub 2020 Jun 15.
- Background: PubMed 18095967Abu-Shahwan I. Effect of propofol on emergence behavior in children after sevoflurane general anesthesia. Paediatr Anaesth. 2008 Jan;18(1):55-9. doi: 10.1111/j.1460-9592.2007.02376.x.
- Derived from this study: PubMed 42688410Ruenhunsa T, Pimonbut S, Sangsungnern P, Wittayapairoch P, Sripadungkul D, Wongsaneha N, Sorit W, Narrutto P. Effect of Low-Dose Propofol Administered at the End of Sevoflurane Anesthesia on Emergence Agitation in Pediatric Patients Undergoing MRI: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Sep 1;2026:6532790. doi: 10.1155/anrp/6532790. eCollection 2026.
- Individual participant dataSharing planned: Yes. all collected individual participant data
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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.
Santhita Pimonbut, M.D. principal investigator
department of anesthesiology, faculty of medicine, Khonkaen 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 Propofol and Normal saline in people with Emergence Agitation, run by Khon Kaen University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 23 Jan 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 Thailand. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Santhita Pimonbut, M.D. (66943624641, Santhita.p@kkumail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of emergence agitation (time frame: at 5,10,15,20,25,30 minutes after extubation). 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 NCT06218680, which also lists 8 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 23 Jan 2024.