Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients

Postoperative Delirium Clinical Trial

— POD-I  

Official title:

Incidence, Long- Term Outcome and Factor Related to Non- Cardiac Postoperative Delirium in Elderly Patients (POD-I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02131181
• Other study ID #: ANE-131366-FB
• Status: Completed
• Phase: N/A
• First received: November 23, 2013
• Last updated: February 2, 2015
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to determine the incidence, long term outcome and factor related to postoperative delirium in elderly patients after non-cardiac surgery.

Description:

The investigators have process of quality assurance for the study including data dictionary, data verification of case record form and site monitoring and auditing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age >/ 60 years

• American Society of Anesthesiologists (ASA) physical status 1-3

• Undergoing scheduled surgery

• Giving an informed consent

Exclusion Criteria:

• Impaired visual and auditory disturbance

• Cannot communicate with Thai language

• Undergoing neurosurgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Chiang Mai University	Maung	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	participants will be followed for the duration of hospital stay, an expected average of 1 week.	participants will be followed for the duration of hospital stay, an expected average of 1 week.	No
Secondary	Factor related to postoperative delirium	Anesthetic technique, Pain score, type of operation	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	Long-term outcomes (cognitive impairment)	This outcome will measure only patients who develop delirium after operation.	3 and 6 months after operation	No

External Links

•   Faculty of Medicine, Chiang Mai, Thailand