Perioperative Risk Factors for Postoperative Delirium in Children

Delirium, Postoperative Clinical Trial

Official title:

Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032161
• Other study ID #: TIHMZK02002
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: February 24, 2013
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

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