Emergence AgitationPhase 4NCT06312618
Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation
A Phase 4 study testing Propofol and Dexmedetomidine in people with Emergence Agitation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is: Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or… Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Propofol and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2024to 15 Mar 2025
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients from 3 to 7 years.
- American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
- Patients undergo squint surgery.
Who cannot join
- Declining to give written informed consent by patient legal guardian.
- Age younger than 3 years or older than 7 years.
- ASA classification ≥ III.
- History of allergy to the medications used in the study or egg products.
- Psychiatric disorder
- Other co-morbidities or congenital anomalies or neurological.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Propofol Versus Dexmedetomidine To Prevent Emergence Agitation After Sevoflurane Anesthesia In Children Undergoing Squint Surgery
The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:
- Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?
Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.
- Conditions
- Emergence Agitation
- Being tested
- Propofol, Dexmedetomidine
- 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
Also called Diprivan
After completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive propofol
1mg/kg over 10 minutes (group 1) .
DexmedetomidineDrug
Also called Precedex
After completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes (group 2).
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Propofol group | Active comparator | children will be randomized to receive propofol 1mg/kg over 10 minutes Receives: Drug: Propofol |
| Group 2: Dexmedetomidine group | Active comparator | children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall incidence of postoperative Emergence Agitation
Pediatric Anesthesia Emergence Delirium (PAED) scale will be use to assess the incidence of Emergence Agitation (EA) A PAED score of 10 or higher is considered to be diagnostic of EA, but a score of 12 or higher is more sensitive and specific.
Measured: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).
Secondary outcomes (6)
heart rate changes
heart rate (HR) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.
Measured: 30 minutes in the PACU
mean arterial pressure (MAP) changes
mean arterial pressure (MAP) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.
Measured: 30 minutes in the PACU
peripheral oxygen saturation (SpO2) changes
peripheral oxygen saturation (SpO2) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.
Measured: 30 minutes in the PACU
Proportion of patients with adverse events in the PACU
including oxygen desaturation defined as SpO2 < 90%, regarded as severe desaturation when SpO2 < 85%, bradycardia defined as HR < 80 beats/min , shivering, dizziness, laryngospasm, severe coughing, and reintubation.
Measured: assessed up to 30 minutes after arrival of patient to PACU.
Proportion of patients with Post Operative Nausea and Vomiting (PONV)
evaluated by a 4-point PONV Scale .
Measured: assessed up to 30 minutes after arrival of patient to PACU.
Time to discharge from the PACU.
the time the patients needs to be stable and discharge from the PACU
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start15 Mar 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312618
- Sponsor's protocol ID
- FMASU MD292/2023
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2024
- Last updated
- 2 Oct 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Propofol Versus Dexmedetomidine To Prevent Emergence Agitation After Sevoflurane Anesthesia In Children Undergoing Squint Surgery
- ClinicalTrials.gov ID
- NCT06312618
- Acronym / sponsor ID
- FMASU MD292/2023
- Conditions
- Emergence Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 15 Mar 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 Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:
- Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?
Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Propofol group | Active comparator | Drug: Propofolchildren will be randomized to receive propofol 1mg/kg over 10 minutes |
| Group 2: Dexmedetomidine group | Active comparator | Drug: Dexmedetomidinechildren will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients from 3 to 7 years.
- American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
- Patients undergo squint surgery.
Key exclusion criteria (6 listed)
- Declining to give written informed consent by patient legal guardian.
- Age younger than 3 years or older than 7 years.
- ASA classification ≥ III.
- History of allergy to the medications used in the study or egg products.
- Psychiatric disorder
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 |
|---|---|---|
| PropofolAlso: DiprivanAfter completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive propofol 1mg/kg over 10 minutes (group 1) . | Drug | Group 1: Propofol group |
| DexmedetomidineAlso: PrecedexAfter completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes (group 2). | Drug | Group 2: Dexmedetomidine group |
Primary outcome
the overall incidence of postoperative Emergence Agitation
Time frame: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).
Pediatric Anesthesia Emergence Delirium (PAED) scale will be use to assess the incidence of Emergence Agitation (EA) A PAED score of 10 or higher is considered to be diagnostic of EA, but a score of 12 or higher is more sensitive and specific.
6 secondary outcomes
heart rate changes
Time frame: 30 minutes in the PACU
mean arterial pressure (MAP) changes
Time frame: 30 minutes in the PACU
peripheral oxygen saturation (SpO2) changes
Time frame: 30 minutes in the PACU
Proportion of patients with adverse events in the PACU
Time frame: assessed up to 30 minutes after arrival of patient to PACU.
Proportion of patients with Post Operative Nausea and Vomiting (PONV)
Time frame: assessed up to 30 minutes after arrival of patient to PACU.
Time to discharge from the PACU.
Time frame: 60 minutes
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 2 Oct 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 4 study testing Propofol and Dexmedetomidine in people with Emergence Agitation, run by Ain Shams University at 1 site in Egypt.
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 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 2 Oct 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 Egypt. 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?
the overall incidence of postoperative Emergence Agitation (time frame: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).). 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 2 Oct 2025.