Perioperative Risk Factors for Postoperative Delirium in Children

Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Delirium, Postoperative

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients between 3 to 12 years old, who were admitted to the PACU after elective non-cardiac surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Delirium; Delirium was determined by RASS-PAEDS
no Delirium; no Delirium was determined by RASS-PAEDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Chuanhan Zhang, M.D., Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Study Chair: Yuke Tian, M.D., Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): February 26, 2013
• Last Update Submitted That Met QC Criteria: February 24, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: surgery; general anesthesia; Postoperative; Delirium; under general anesthesia; Non-cardiovascular surgery; Post-anaesthesia care unit; patients between 3 to 12 years old; undergoing selective non-cardiac surgery
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: TIHMZK02002