NCT00991913

Brief Summary

Despite recent advances in postoperative delirium research, the proportion of patients with postoperative delirium is still high ranging between 20-80%. 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 patients undergoing non cardiovascular surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2010

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

29 days

First QC Date

October 7, 2009

Last Update Submit

July 20, 2020

Conditions

Keywords

DeliriumPostoperativeNon-cardiovascular surgeryPost-anaesthesia care unit

Outcome Measures

Primary Outcomes (1)

  • The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria

    at 1 hour after operation

Secondary Outcomes (4)

  • heart rate in PACU

    every 10 mins

  • Pulse Oximeter Oxygen Saturation (SpO2) in PACU

    every 10 mins

  • Hospital-length of stay

    up to 6 months

  • Total health care fees

    up to 6 months

Study Arms (2)

Delirium

Delirium was determined by CAM-ICU

no Delirium

no Delirium was determined by CAM-ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18yr, who were admitted to the PACU after elective surgery under general anaesthesia during regular working hours (9:00Am to 5:00Pm)

You may qualify if:

  • elective non-cardiovascular surgery
  • general anesthesia

You may not qualify if:

  • under 18yr of age
  • under regional anaesthesia
  • refused to sign consent form
  • history of substance dependence
  • underwent neurosurgery
  • history of primary neurologic diseases
  • stayed less than 10min in PACU
  • received general anaesthesia but recovered in locations outside the recovery room

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Yuke Tian, MD.

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

June 1, 2010

Primary Completion

June 30, 2010

Study Completion

June 30, 2010

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations