Emergence AgitationPhase 4NCT07601698
Dexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia
A Phase 4 study testing Dexmedetomidine and Propofol in people with Emergence Agitation, run by Sohag University.
Trial summary
Primary we will Compare the Efficacy between Dexmedetomidine and "Propofol-lidocaine" mixture in preventing the post operative emergence agitation following sevoflurane anasthesia in pediatric ophthalmic surgeries Secondary we will evaluate time of extubation, time of orientation, Hemodynamic variables, Visual analog… Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Dexmedetomidine and Propofol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to Dec 2026
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients aged 2-8 years .
- ASA physical status I-II.
- Scheduled for elective surgeries under general anesthesia with sevoflurane
Who cannot join
- History of psychiatric illness or cognitive impairment.
- Known allergy to study drugs.
- Severe cardiovascular, hepatic, or renal disease.
- Chronic use of sedatives or opioids.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
elhadad ali mousa, professor contact
About this study
Official title: The Efficacy of Dexmedetomidine Versus Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anesthesia in Pediatric Ophthalmic Surgeries , A Prospective Randomized Comparative Controlled Study
Primary we will Compare the Efficacy between Dexmedetomidine and "Propofol-lidocaine" mixture in preventing the post operative emergence agitation following sevoflurane anasthesia in pediatric ophthalmic surgeries Secondary we will evaluate time of extubation, time of orientation, Hemodynamic variables, Visual analog scale ( VAS), facial expressions scale , Adverse events
Read the detailed description
Emergence agitation (EA) is a frequent and distressing complication in pediatric anesthesia, particularly following the use of volatile agents such as sevoflurane. It is characterized by restlessness, inconsolable crying, disorientation, and incongruent behavior during the early recovery period from general anesthesia (Dahmani S et al.,2014 ). Although EA is usually self-limited, it may cause harm to patients by leading to self-injury, disruption of surgical sites, removal of intravenous lines, or increased stress for caregivers and healthcare providers. The reported incidence of EA in children ranges between 10% and 80%, with higher prevalence observed in younger patients and in ophthalmic surgeries due to sensory deprivation and postoperative discomfort (Dahmani S et al.,2014 ). Sevoflurane remains the most widely used inhalational agent in pediatric anesthesia because of its rapid induction, low airway irritability, and favorable hemodynamic profile. However, it has been consistently associated with a higher risk of EA compared with other anesthetic techniques (Zhang Y et al., 2022) - (Liu J et al., 2022). Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has emerged as a promising agent due to its sedative, analgesic, and anxiolytic properties without significant respiratory depression (Zhang Y et al., 2022) - (Liu J et al., 2022). Several studies have demonstrated its efficacy in reducing the incidence and severity of EA when administered perioperatively (Zhang Y et al., 2022)- (Abdel-Ghaffar HS et al., 2019). On the other hand, propofol, a short-acting intravenous anesthetic with sedative and antiemetic properties, has also been investigated for EA prevention. When combined with lidocaine, propofol infusion provides not only smooth sedation and rapid recovery but also decreases pain associated with injection and potentially modulates airway reflexes and emergence agitation (Kim YH et al., 2014). Previous studies have shown that a single bolus dose of propofol at the end of surgery can reduce EA incidence in children undergoing ophthalmic surgery (Aouad MT t al., 2007). Meta-analyses further confirmed the beneficial role of propofol in reducing EA and improving recovery profiles (Liu J et al.,2022) -(Li Y et al.,2019). In ophthalmic surgeries for young children, smooth emergence from anesthesia is crucial, as agitation can compromise surgical outcomes, increase the risk of complications, and delay recovery (Kim YH et al., 2014)- (Aouad MT t al., 2007).
- Conditions
- Emergence Agitation
- Being tested
- Dexmedetomidine, Propofol, Placebo
- Keywords
- EA
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery
PropofolDrug
Propofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery.
PlaceboDrug
receive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Dexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery Receives: Drug: Dexmedetomidine |
| Propofol plus lidocaine | Experimental | Propofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery Receives: Drug: Propofol |
| placebo | Placebo comparator | receive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation
Incidence of emergence agitation assessed using Aono's Four-Point Scale after extubation in pediatric patients undergoing ophthalmic surgery under sevoflurane anesthesia.
Measured: Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)
Secondary outcomes (5)
Time to extubation
The interval between discontinuation of anesthetic agents and successful extubation.
Measured: From discontinuation of anesthesia until extubation, up to 30 minutes
Time to orientation
The interval between discontinuation of anesthetic agents and recovery of adequate consciousness to follow simple commands.
Measured: During recovery period in PACU, up to 30 minutes postoperatively
Hemodynamic variables
Assessment of heart rate during emergence and recovery period.
Measured: From baseline until 30 minutes postoperatively
Postoperative pain score
Assessment of postoperative pain using Wong-Baker FACES scale according to patient age.
Measured: During the first 4 postoperative hours
Adverse events
Incidence of adverse events including bradycardia, hypotension, nausea, vomiting, respiratory depression, and postoperative nausea and vomiting.
Measured: During surgery and within the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Sohag 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taher Mohamed Aboelyamin, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601698
- Sponsor's protocol ID
- EA in sevofluran in anesthesia
- Status last verified
- May 2026
- First submitted
- 9 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dexmedetomidine Versus Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anesthesia in Pediatric Ophthalmic Surgeries , A Prospective Randomized Comparative Controlled Study
- ClinicalTrials.gov ID
- NCT07601698
- Acronym / sponsor ID
- EA in sevofluran in anesthesia
- Conditions
- Emergence Agitation
- Keywords
- EA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2026 (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.
Primary we will Compare the Efficacy between Dexmedetomidine and "Propofol-lidocaine" mixture in preventing the post operative emergence agitation following sevoflurane anasthesia in pediatric ophthalmic surgeries Secondary we will evaluate time of extubation, time of orientation, Hemodynamic variables, Visual analog scale ( VAS), facial expressions scale , Adverse events
Detailed description
Emergence agitation (EA) is a frequent and distressing complication in pediatric anesthesia, particularly following the use of volatile agents such as sevoflurane. It is characterized by restlessness, inconsolable crying, disorientation, and incongruent behavior during the early recovery period from general anesthesia (Dahmani S et al.,2014 ). Although EA is usually self-limited, it may cause harm to patients by leading to self-injury, disruption of surgical sites, removal of intravenous lines, or increased stress for caregivers and healthcare providers. The reported incidence of EA in children ranges between 10% and 80%, with higher prevalence observed in younger patients and in ophthalmic surgeries due to sensory deprivation and postoperative discomfort (Dahmani S et al.,2014 ). Sevoflurane remains the most widely used inhalational agent in pediatric anesthesia because of its rapid induction, low airway irritability, and favorable hemodynamic profile. However, it has been consistently associated with a higher risk of EA compared with other anesthetic techniques (Zhang Y et al., 2022) - (Liu J et al., 2022). Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has emerged as a promising agent due to its sedative, analgesic, and anxiolytic properties without significant respiratory depression (Zhang Y et al., 2022) - (Liu J et al., 2022). Several studies have demonstrated its efficacy in reducing the incidence and severity of EA when administered perioperatively (Zhang Y et al., 2022)- (Abdel-Ghaffar HS et al., 2019). On the other hand, propofol, a short-acting intravenous anesthetic with sedative and antiemetic properties, has also been investigated for EA prevention. When combined with lidocaine, propofol infusion provides not only smooth sedation and rapid recovery but also decreases pain associated with injection and potentially modulates airway reflexes and emergence agitation (Kim YH et al., 2014). Previous studies have shown that a single bolus dose of propofol at the end of surgery can reduce EA incidence in children undergoing ophthalmic surgery (Aouad MT t al., 2007). Meta-analyses further confirmed the beneficial role of propofol in reducing EA and improving recovery profiles (Liu J et al.,2022) -(Li Y et al.,2019). In ophthalmic surgeries for young children, smooth emergence from anesthesia is crucial, as agitation can compromise surgical outcomes, increase the risk of complications, and delay recovery (Kim YH et al., 2014)- (Aouad MT t al., 2007).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery |
| Propofol plus lidocaine | Experimental | Drug: PropofolPropofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery |
| placebo | Placebo comparator | Drug: Placeboreceive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients aged 2-8 years .
- ASA physical status I-II.
- Scheduled for elective surgeries under general anesthesia with sevoflurane
Key exclusion criteria (4 listed)
- History of psychiatric illness or cognitive impairment.
- Known allergy to study drugs.
- Severe cardiovascular, hepatic, or renal disease.
- Chronic use of sedatives or opioids.
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery | Drug | dexmedetomidine |
| PropofolPropofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery. | Drug | Propofol plus lidocaine |
| Placeboreceive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery | Drug | placebo |
Primary outcome
Incidence of emergence agitation
Time frame: Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)
Incidence of emergence agitation assessed using Aono's Four-Point Scale after extubation in pediatric patients undergoing ophthalmic surgery under sevoflurane anesthesia.
5 secondary outcomes
Time to extubation
Time frame: From discontinuation of anesthesia until extubation, up to 30 minutes
Time to orientation
Time frame: During recovery period in PACU, up to 30 minutes postoperatively
Hemodynamic variables
Time frame: From baseline until 30 minutes postoperatively
Postoperative pain score
Time frame: During the first 4 postoperative hours
Adverse events
Time frame: During surgery and within the first 24 postoperative hours
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 May 2026.
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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.
elhadad ali mousa, professor contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Propofol in people with Emergence Agitation, run by Sohag University.
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 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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact taher mohamed, residant (01120799228, taher2014mohamed@yahoo.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: Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)). 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 May 2026.