- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04193280
Blood Sugar Level and Postoperative Agitations in Pediatric Surgery
Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Emergence delirium is a very important clinic phenomenon, characterized by irritability and severe restlessness in children recovering from anesthesia; it may cause injury to the child recovering from anesthesia or to surgical site and may also lead to parents, who witness emergence delirium to question the quality of anesthesia. Postoperative agitaitons, has been noted with the newer, less soluble inhaled agents and emergence delirium has become a serious problem, taken care in postanesthesia care unit for anesthesiologists. Preoperative anxiety, premedication, anesthetic drugs, pain, type of surgery and emergence in a foreign environment are the factors which take part in the development of emergence delirium. Emotional and less social children, the children with anxious parents, children undergoing upper airway surgery are under risk. Detection of children at risk, the use of appropriate adjuvant drugs, strict control of postoperative pain, and accompanying parents to their children in the recovery room are currently the primary measures to prevent recovery agitation. Further studies are required to discover underlying causes and management of emergence delirium.
In this study pre-and postoperative blood glucose values, preoperative fasting times and hemodynamic values of 200 American Society of Anesthesiologists (ASA) physical status I-2 patients will be recorded. At the end of the operation, patients will be evaluated with Modified Aldrete Sedation Scale, FLACC Pain Rating Scale and PAED Agitation Scale. The results obtained will be evaluated with statistical methods and the relationship between preoperative fasting time and blood glucose levels and postoperative agitations will be investigated.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Istanbul, Kalkun, 34730
- Rekruttering
- Istanbul MU Goztepe Training and Research Hospital
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Kontakt:
- ZEYNEP N ORHON
- Telefonnummer: 02165664000
- E-mail: zeynepnurorhon@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Pediatric patients between 2-12 years of age who will undergo outpatient surgery
Exclusion Criteria:
- ASA III-IV patients, patients with congenital malformation and developmental delays, or any neurological or cardiac diseases
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Blood sugar level
Tidsramme: 11.1.2019-5.31.2020
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Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.
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11.1.2019-5.31.2020
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The fasting time
Tidsramme: 11.1.2019-5.31.2020
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Fasting time will be recorded.
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11.1.2019-5.31.2020
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The change in blood sugar level
Tidsramme: 11.1.2019-5.31.2020
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According to the type of operation, the change in blood sugar level will be detected.
Correlation of this change with postoperative agitation will be investigated
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11.1.2019-5.31.2020
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zeynep N Orhon, MD, Istanbul Medeniyet University Goztepe Research and Traininig Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IstanbulMUPediatricAnesthesia
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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