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Completed

NCT Number: NCT01032161

Perioperative Risk Factors for Postoperative Delirium in Children

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.

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Key information

Conditions

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

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Maximal and minimal heart rate in PACU

    Time frame: every 15 min during PACU stay

  2. Pulse Oximeter Oxygen Saturation (SpO2) in PACU

    Time frame: every 15 min during PACU stay

  3. Hospital-length of stay

    Time frame: before discharge

  4. Total health care fees

    Time frame: during hospital stay

  5. Quality of recovery measured by PACBIS criteria

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

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2009
Registry last updated
Feb 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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