Blood Sugar Level and Postoperative Agitations in Pediatric Surgery

• Conditions: Postoperative Delirium

• Registration Number: NCT04193280
• Lead Sponsor: Istanbul Medeniyet University

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.

Study Timeline

• Study Start: 2019-11-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-08
• Last Update Submitted: 2019-12-08
• Study First Posted: 2019-12-10
• Last Update Posted: 2019-12-10
• Primary Completion: 2020-05-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood sugar level	11.1.2019-5.31.2020	Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.
The fasting time	11.1.2019-5.31.2020	Fasting time will be recorded.
The change in blood sugar level	11.1.2019-5.31.2020	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

Trial Locations

Locations (1)

Istanbul MU Goztepe Training and Research Hospital; 🇹🇷 Istanbul, Turkey