Blood Sugar Level and Postoperative Agitations in Pediatric Surgery

Postoperative Delirium Clinical Trial

Official title:

Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04193280
• Other study ID #: IstanbulMUPediatricAnesthesia
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2019
• Source: Istanbul Medeniyet University
• Contact: Zeynep N Orhon, MD
• Phone: 02165664000
• Email: zeynepnurorhon[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
Turkey	Istanbul MU Goztepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood sugar level	Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.	11.1.2019-5.31.2020
Primary	The fasting time	Fasting time will be recorded.	11.1.2019-5.31.2020
Primary	The change in blood sugar level	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	11.1.2019-5.31.2020