Perioperative Risk Factors for Postoperative Delirium in Children

Completed

• Conditions: Delirium, Postoperative

• Registration Number: NCT01032161
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

Despite recent advances in postoperative delirium research, the proportion of children with postoperative delirium is still high. Although postoperative delirium is a frequent complication and is associated with the need for more inpatient hospital care and longer length of hospital stay, little is known about risk factors for recovery room delirium (RRD) occurred in postanaesthesia care unit. The aim of the study was to determine pre- and intraoperative risk factors for the development of RRD among children undergoing non cardiovascular surgery.

Detailed Description

Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to RASS-PAEDS criteria. Pre-, intra-, and postoperative data of patients undergoing elective non cardiovascular surgery were prospectively collected, univariate and multivariate logistic regression were performed to find the risk factors related to postoperative delirium.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-24
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• between 3 to 12 years old
• elective non-cardiovascular surgery
• general anesthesia

Exclusion Criteria

• under regional anaesthesia
• instable vital sign
• without consent form
• underwent neurosurgery
• history of primary neurologic diseases
• stayed less than 10min in PACU
• received general anaesthesia but recovered in locations outside the recovery room

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria	at 1, 8, 16, 24, 48 and 72 postoperative hour

Secondary Outcome Measures

Name	Time	Method
Maximal and minimal heart rate in PACU	every 15 min during PACU stay
Pulse Oximeter Oxygen Saturation (SpO2) in PACU	every 15 min during PACU stay
Hospital-length of stay	before discharge
Total health care fees	during hospital stay
Quality of recovery measured by PACBIS criteria	at 1, 8, 16, 24, 48 and 72 postoperative hour

Trial Locations

Locations (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China