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

Delirium Clinical Trial

Official title:

Risk Factors of Recovery Room Delirium After Elective Non-cardiovascular Surgery in Post-anaesthesia Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991913
• Other study ID #: TJHMZK02001
• Status: Completed
• Start date: June 1, 2010
• Est. completion date: June 30, 2010

Study information

• Verified date: July 2020
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Recovery room delirium (RRD) defined as delirium occurred in PACU was diagnosed according to CAM-ICU 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: June 30, 2010
• Est. primary completion date: June 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
China	Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of delirium in post anesthesia care unit (PACU) determined by confusion assessment method (CAM) -ICU criteria		at 1 hour after operation
Secondary	heart rate in PACU	heart rate was recorded every 10 min during PACU stay, maximal and minimal heart rate were collected for analysis	every 10 mins
Secondary	Pulse Oximeter Oxygen Saturation (SpO2) in PACU		every 10 mins
Secondary	Hospital-length of stay		up to 6 months
Secondary	Total health care fees		up to 6 months