Effects of Perioperative Operating Room Environment on Postoperative Delirium

Effects of Perioperative Operating Room Environment on Postoperative Delirium in Elderly Patients With Abdominal Surgery : A Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium

• Study Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: HUANG HE, MD; Phone Number: (+86)13708385559; Email: huanghe@cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
      • Contact: He Huang, M.D.; Phone Number: (+86)13708385559; Email: huanghe@cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Elderly patients who underwent abdominal surgery under general anesthesia.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Investigators: Study Director: Jia Tang, MD, Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): February 26, 2024

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: Factors of POD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No