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Perioperative Risk Factors for Postoperative Delirium in Children

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ClinicalTrials.gov Identifier: NCT01032161
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

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.

Condition or disease
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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Delirium
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032161


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

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01032161     History of Changes
Other Study ID Numbers: TIHMZK02002
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Wei Mei, Huazhong University of Science and Technology:
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

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs