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Dexmedetomidine vs Propofol-lidocaine Mixture in Preventing the Post Operative Emergence Agitation Following Sevoflurane Anasthesia

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07601698
Enrollment
200
Registered
2026-05-22
Start date
2026-05-01
Completion date
2026-12-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

Keywords

EA

Brief 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 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).

Interventions

DRUGDexmedetomidine

Dexmedetomidine 0.3mcg /kg over diluted in 10 ml 0.9% Na cl over 10 min and 10 min before end of surgery

DRUGPropofol

Propofol 2mg/kg plus lidocaine 1mg/kg over 10 min and 10 min before end of surgery.

DRUGPlacebo

receive placebo 10 ml 0.9% Nacl over 10 min and 10 min before end of surgery

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

* patients aged 2-8 years . * ASA physical status I-II. * Scheduled for elective surgeries under general anesthesia with sevoflurane

Exclusion criteria

* History of psychiatric illness or cognitive impairment. * Known allergy to study drugs. * Severe cardiovascular, hepatic, or renal disease. * Chronic use of sedatives or opioids.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of emergence agitationAssessed 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.

Secondary

MeasureTime frameDescription
Time to extubationFrom discontinuation of anesthesia until extubation, up to 30 minutesThe interval between discontinuation of anesthetic agents and successful extubation.
Time to orientationDuring recovery period in PACU, up to 30 minutes postoperativelyThe interval between discontinuation of anesthetic agents and recovery of adequate consciousness to follow simple commands.
Hemodynamic variablesFrom baseline until 30 minutes postoperativelyAssessment of heart rate during emergence and recovery period.
Postoperative pain scoreDuring the first 4 postoperative hoursAssessment of postoperative pain using Wong-Baker FACES scale according to patient age.
Adverse eventsDuring surgery and within the first 24 postoperative hoursIncidence of adverse events including bradycardia, hypotension, nausea, vomiting, respiratory depression, and postoperative nausea and vomiting.

Contacts

CONTACTtaher mohamed, residant
taher2014mohamed@yahoo.com01120799228
CONTACTelhadad ali mousa, professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026