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Clinical Trials/NCT01032161
NCT01032161
Completed
Not Applicable

Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia

Huazhong University of Science and Technology1 site in 1 country300 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium, Postoperative
Sponsor
Huazhong University of Science and Technology
Enrollment
300
Locations
1
Primary Endpoint
The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
December 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wei Mei

Associate Professor

Huazhong University of Science and Technology

Eligibility Criteria

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

Outcomes

Primary Outcomes

The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria

Time Frame: at 1, 8, 16, 24, 48 and 72 postoperative hour

Secondary Outcomes

  • 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 Sites (1)

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