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Perioperative Risk Factors for Postoperative Delirium in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01032161
First received: December 14, 2009
Last updated: February 24, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Delirium, Postoperative

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximal and minimal heart rate in PACU [ Time Frame: every 15 min during PACU stay ] [ Designated as safety issue: Yes ]
  • Pulse Oximeter Oxygen Saturation (SpO2) in PACU [ Time Frame: every 15 min during PACU stay ] [ Designated as safety issue: Yes ]
  • Hospital-length of stay [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
  • Total health care fees [ Time Frame: during hospital stay ] [ Designated as safety issue: Yes ]
  • Quality of recovery measured by PACBIS criteria [ Time Frame: at 1, 8, 16, 24, 48 and 72 postoperative hour ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Delirium
Delirium was determined by RASS-PAEDS
no Delirium
no Delirium was determined by RASS-PAEDS

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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Wei Mei, Associate Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01032161     History of Changes
Other Study ID Numbers: TIHMZK02002
Study First Received: December 14, 2009
Last Updated: February 24, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013