Clinical trial NCT04193280: Blood Sugar Level and Postoperative Agitations in Pediatric Surgery
Official title: Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Keywords: Preoperative fasting time,
Blood glucose level
Postoperative Delirium
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include children between 2-12 years of age who will be operated in the pediatric operating room. Circumcision, inguinal hernia, undescended testis, lymphadenopathy excision, cystoscopy, adenotonsillectomy cases will be included in the study.

Brief summary: The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood sugar level
timeFrame: 11.1.2019-5.31.2020
measure: The fasting time
timeFrame: 11.1.2019-5.31.2020
measure: The change in blood sugar level
timeFrame: 11.1.2019-5.31.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul MU Goztepe Training and Research Hospital
Study officials:
affiliation: Istanbul Medeniyet University Goztepe Research and Traininig Hospital
name: Zeynep N Orhon, MD
role: PRINCIPAL_INVESTIGATOR
References: