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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05551026
Other study ID # Factors of POD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 22, 2022
Est. completion date February 26, 2024

Study information

Verified date December 2022
Source The Second Affiliated Hospital of Chongqing Medical University
Contact Huang He, MD
Phone (+86)13708385559
Email huanghe@cqmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thi investigators aims to observe the impact of perioperative body temperature and the noise of operating room on postoperative delirium for elderly patients undergoing abdominal surgery. And based on this study the investigators aimed to explore the potential risk factors of postoperative delirium for elderly patients undergoing abdominal surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date February 26, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 90 Years
Eligibility Inclusion Criteria: - Age 65-90 years old; - ASA I-III; - Patients who plan to undergo elective abdominal surgery under general anesthesia; - Volunteer to participate in this study and sign informed consent. Exclusion Criteria: - Patients with known mental illness or lack of communication or cognitive impairment before operation; - Severe vision, hearing, language impairment or other reasons unable to communicate with visitors; - Severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.; - Long-term use of sedatives, antidepressants or alcoholism; - Patients with severe postoperative complications and admitted to intensive care unit; - Patients who refused or failed to complete the cognitive function test. - Patients who could not cooperate with the study for any other reason.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
The Second Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative delirium during the 3 days-follow-up after anesthetic resuscitation Postoperative delirium was tested with 3 minutes-Confusion Assessment Method or Confusion Assessment Method-intensive care unit (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder. From ending of the surgery to 3 days after anesthetic resuscitation
Secondary Postoperative delirium in the postanesthesia care unit Postoperative delirium was tested with 3 minutes-Confusion Assessment Method (0-4, higher scores means worse outcome). The patient is determined to be postoperative delirium (ie, Confusion Assessment Method positive) if he/she fall ill quickly with confusion disorder, and with mental disorder or consciousness disorder. From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes
Secondary Hospital stay Time duration of the patients' stay in hospital From the ending of the surgery to hospital discharge, with means of about 7 days
Secondary Postoperative complication The number of patients who having complication during the hospitalization From the ending of the surgery to hospital discharge, with means of about 7 days
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