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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

taher mohamed, residant contact

01120799228

taher2014mohamed@yahoo.com

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).

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 groups in NCT07601698
Study groupRoleWhat they receive
dexmedetomidineExperimentalDexmedetomidine 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 lidocaineExperimentalPropofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery
Receives: Drug: Propofol
placeboPlacebo comparatorreceive 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.

  1. 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)
  1. Time to extubation

    The interval between discontinuation of anesthetic agents and successful extubation.

    Measured: From discontinuation of anesthesia until extubation, up to 30 minutes

  2. 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

  3. Hemodynamic variables

    Assessment of heart rate during emergence and recovery period.

    Measured: From baseline until 30 minutes postoperatively

  4. Postoperative pain score

    Assessment of postoperative pain using Wong-Baker FACES scale according to patient age.

    Measured: During the first 4 postoperative hours

  5. 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.

  1. First posted22 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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

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.

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