Perioperative Risk Factors for Postoperative Delirium in Children

NCT01032161 | Completed DMC

• 1 other identifier: TIHMZK02002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium, Postoperative

Keywords

Delirium; Postoperative; Non-cardiovascular surgery; Post-anaesthesia care unit; patients between 3 to 12 years old; undergoing selective non-cardiac surgery; under general anesthesia; surgery; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Delirium

Delirium was determined by RASS-PAEDS

no Delirium

no Delirium was determined by RASS-PAEDS

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chuanhan Zhang, M.D.

  Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

• Yuke Tian, M.D.

  Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

CN (1)