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

ConditionEmergence Agitation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-8
SponsorSohag University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

patients aged 2-8 years .

ASA physical status I-II.

Scheduled for elective surgeries under general anesthesia with sevoflurane

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: dexmedetomidineExperimental treatment 1 intervention
Group B: Propofol plus lidocaineExperimental treatment 1 intervention
Group C: placeboPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Time to extubation

The interval between discontinuation of anesthetic agents and successful extubation.

Time frame
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.

Time frame
During recovery period in PACU, up to 30 minutes postoperatively
3

Hemodynamic variables

Assessment of heart rate during emergence and recovery period.

Time frame
From baseline until 30 minutes postoperatively
4

Postoperative pain score

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

Time frame
During the first 4 postoperative hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sohag University

Lead sponsor

Source ClinicalTrials.gov

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