- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04193280
Blood Sugar Level and Postoperative Agitations in Pediatric Surgery
Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Istanbul, Tyrkia, 34730
- Rekruttering
- Istanbul MU Goztepe Training and Research Hospital
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Ta kontakt med:
- ZEYNEP N ORHON
- Telefonnummer: 02165664000
- E-post: zeynepnurorhon@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Zeynep N Orhon, MD, Istanbul Medeniyet University Goztepe Research and Traininig Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IstanbulMUPediatricAnesthesia
Legemiddel- og utstyrsinformasjon, studiedokumenter
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