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NCT Number: NCT07601698

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

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Propofol

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to extubation

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

    The interval between discontinuation of anesthetic agents and successful extubation.

  2. Time to orientation

    Time frame: During recovery period in PACU, up to 30 minutes postoperatively

    The interval between discontinuation of anesthetic agents and recovery of adequate consciousness to follow simple commands.

  3. Hemodynamic variables

    Time frame: From baseline until 30 minutes postoperatively

    Assessment of heart rate during emergence and recovery period.

  4. Postoperative pain score

    Time frame: During the first 4 postoperative hours

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

  5. Adverse events

    Time frame: During surgery and within the first 24 postoperative hours

    Incidence of adverse events including bradycardia, hypotension, nausea, vomiting, respiratory depression, and postoperative nausea and vomiting.

Study contacts

Contact information is provided by the study sponsor or research team.

elhadad ali mousa, professor

CONTACT

taher mohamed, residant

CONTACT

[email protected]

01120799228

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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