Clinical trial NCT01032161: Perioperative Risk Factors for Postoperative Delirium in Children
Official title: Perioperative Risk Factors for Postoperative Delirium in Children Following General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium, Postoperative
Keywords: 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
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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

Primary outcomes:
measure: The presence of delirium in post anesthesia care unit (PACU) and in ward determined by RASS-PAEDS criteria
timeFrame: at 1, 8, 16, 24, 48 and 72 postoperative hour
Secondary outcomes:
measure: Maximal and minimal heart rate in PACU
timeFrame: every 15 min during PACU stay
measure: Pulse Oximeter Oxygen Saturation (SpO2) in PACU
timeFrame: every 15 min during PACU stay
measure: Hospital-length of stay
timeFrame: before discharge
measure: Total health care fees
timeFrame: during hospital stay
measure: Quality of recovery measured by PACBIS criteria
timeFrame: at 1, 8, 16, 24, 48 and 72 postoperative hour
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Chuanhan Zhang, M.D.
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, M.D.
role: STUDY_CHAIR
References: