Blood Sugar Level and Postoperative Agitations in Pediatric Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Delirium

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Zeynep N Orhon, MD; Phone Number: 02165664000; Email: zeynepnurorhon@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34730
    • Recruiting
    • Istanbul MU Goztepe Training and Research Hospital
    • Contact: ZEYNEP N ORHON; Phone Number: 02165664000; Email: zeynepnurorhon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood sugar level	Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.	11.1.2019-5.31.2020
The fasting time	Fasting time will be recorded.	11.1.2019-5.31.2020
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

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Principal Investigator: Zeynep N Orhon, MD, Istanbul Medeniyet University Goztepe Research and Traininig Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 8, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative Delirium; Blood glucose level; Preoperative fasting time,
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: IstanbulMUPediatricAnesthesia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No