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The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics

A legfontosabb adatok

Ki végzi
Istanbul University
Hol
Törökország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Befejeződött
Résztvevők
250 fő vett részt
Kezdés
2024. febr. 22.
Befejezés
2025. márc. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • MAC adjustment to PSI between 25 and 50
A regiszteradat frissítve
2025. április 8.

Ki vehet részt

Életkor
2 év – 8 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 9 feltétel megnézéseKevesebb

Ki vehet részt

  • 2 to 8 years old
  • Surgery time > 1 hour
  • Urology, Plastic Surgery and Pediatric Surgery patients

Ki nem vehet részt

  • Patients receiving intraoperative ketamine administration
  • Patients with a history of epilepsy/antiepileptic treatment
  • Surgeries performed under emergency conditions
  • Patients with neuromotor development abnormalities
  • Patients requiring postoperative ICU admission
  • Patients without parental consent

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.

A teljes eredeti leírásKevesebb

Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.

In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of >12 points for the diagnosis of ED is 100% and the specificity is 94.5%.

Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.

There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.

A vizsgálat 2 csoportja

  • Control GroupNincs vizsgálati kezelés, összehasonlításként

    Sevoflurane anesthesia will be applied with an endtidal agent consumption of 0.8 MACage, with 2 standard deviations for MACage:1 to the control group, as we apply in routine anesthesia practice. (During the surgery, the parameters showing the depth of anesthesia will be placed away from the anesthesiologist and covered to ensure blindness. At the end of the surgery, the data will be received via USB.)

  • Study GroupA vizsgált kezelés

    Sevoflurane anesthesia will be applied to the study group by adjusting the MAC to keep the PSI median value between 25-50 (if PSI\<25, MAC will be reduced by 0.1, if PSI\>50, MAC will be increased by 0.1).

    Kezelés: MAC adjustment to PSI between 25 and 50

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
The Effect of Anesthesia Depth Monitoring on Emergence Agitation and Delirium in Pediatrics
A regiszteradat frissítve
2025. április 8.