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

NCT07601698 | Not Yet Recruiting Phase 4

• 1 other identifier: EA in sevofluran in anesthesia
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Emergence Agitation

Keywords

EA

Outcome Measures

Primary Outcomes (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.

  Assessed at 5, 10, 15, and 30 minutes after extubation in the post-anesthesia care unit (PACU)

Secondary Outcomes (5)

• Time to extubation

  From discontinuation of anesthesia until extubation, up to 30 minutes

• Time to orientation

  During recovery period in PACU, up to 30 minutes postoperatively

• Hemodynamic variables

  From baseline until 30 minutes postoperatively

• Postoperative pain score

  During the first 4 postoperative hours

• Adverse events

  During surgery and within the first 24 postoperative hours

Study Arms (3)

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

Drug: Dexmedetomidine

Propofol plus lidocaine

EXPERIMENTAL

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

Drug: Propofol

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

dexmedetomidine

Propofol DRUG

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

Propofol plus lidocaine

Placebo DRUG

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

placebo

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

taher mohamed, residant

CONTACT

01120799228; taher2014mohamed@yahoo.com

elhadad ali mousa, professor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical ICU and Pain Medicine

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05