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The Effect of Paedfusor TCI, Eleveld TCI, and Sevoflurane Anesthesia on Postoperative Awakening Agitation in Pediatric Patients

ConditionsEmergence Delirium in Pediatric AnesthesiaPediatric AnesthesiaPostoperative Agitations in Pediatric PatientsPostoperative Nausea and Vomiting (PONV)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-10
SponsorMarmara University Pendik Training and Research Hospital

About this trial

Emergence delirium is a common complication in pediatric patients undergoing general anesthesia. The aim of this study is to investigate the incidence of postoperative awakening delirium and agitation in pediatric patients aged 3-10 years (ASA I-II) using two different target-controlled infusion (TCI) methods (Paedfusor and Eleveld) for TIVA, compared to inhalation anesthesia. This study will examine the effect of two different TCI models on postoperative awakening agitation/delirium by comparing them with each other and with inhalation anesthesia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 3-10 years

Children weighing over 10 kg

American Society of Anesthesiologists (ASA) physical condition classification I-II

Those who will undergo planned urogenital surgery under general anesthesia

Disqualifiers

Patients assessed as ASA III or higher

Known neurological or psychiatric disorders

Developmental delay or cognitive impairment

Use of sedatives or psychoactive drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • propofol ( Paedfusor Model)

    Drug

    Propofol will be administered via target-controlled infusion using a Paedfusor model.

  • propofol (Eleveld Model)

    Drug

    Propofol will be administered via target-controlled infusion using the Eleveld model.

  • Sevofluorane

    Drug

    Sevoflurane will be administered as an inhalation anesthetic.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Paedfusor GroupExperimental treatment 1 intervention
Group B: Eleveld GroupExperimental treatment 1 intervention
Group C: Sevoflurane GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Emergence Delirium Assessed by PAED Scale

Postoperative awakening delirium and its severity will be assessed using the Pediatric Anesthesia Awakening Delirium (PAED) scale.

Time frame
Within the first 30 minutes after emergence from anesthesia

Secondary outcomes

1

Postoperative Pain Assessed by FLACC Scale

Postoperative pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.

Time frame
Within the first 120 minutes after surgery
2

Association Between BIS-Derived Alpha Band Power and Emergence Delirium

The relationship between bispectral index (BIS)-derived alpha frequency band power and emergence delirium will be evaluated in patients who develop emergence delirium.

Time frame
Intraoperative period
3

Time to Emergence

Time from discontinuation of anesthesia to eye opening and response to verbal stimuli.

Time frame
Within the first 120 minutes after surgery
4

Incidence of Postoperative Nausea and Vomiting

Occurrence of nausea and/or vomiting in the postoperative period.

Time frame
Within 30 minutes after the surgery

Other outcomes

Sponsors and contacts

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

Marmara University Pendik Training and Research Hospital

Lead sponsor

Source ClinicalTrials.gov
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