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Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00991913
First received: October 7, 2009
Last updated: May 28, 2013
Last verified: May 2013
  Purpose
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.

Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery in Post-anaesthesia Care Unit

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The presence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) criteria [ Time Frame: at 1 hour after operation ]

Secondary Outcome Measures:
  • heart rate in PACU [ Time Frame: every 10 mins ]
    heart rate was recorded every 10 min during PACU stay, maximal and minimal heart rate were collected for analysis

  • Pulse Oximeter Oxygen Saturation (SpO2) in PACU [ Time Frame: every 10 mins ]
  • Hospital-length of stay [ Time Frame: up to 6 months ]
  • Total health care fees [ Time Frame: up to 6 months ]

Enrollment: 715
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Delirium
Delirium was determined by CAM
no Delirium
no Delirium was determined by CAM

Detailed Description:
Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to CAM 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:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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)
Criteria

Inclusion Criteria:

  • elective non-cardiovascular surgery
  • general anesthesia

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991913

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 Chair: Yuke Tian, MD. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  More Information

Responsible Party: Wei Mei, Department of Anesthesiology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT00991913     History of Changes
Other Study ID Numbers: TJHMZK02001
Study First Received: October 7, 2009
Last Updated: May 28, 2013

Keywords provided by Wei Mei, Huazhong University of Science and Technology:
Delirium
Postoperative
Non-cardiovascular surgery
Post-anaesthesia care unit

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017