The Impact of Smoking on the Prognosis of Elderly Surgical Patients

Delirium, Postoperative Clinical Trial

Official title:

The Impact of Smoking on Postoperative Delirium and Recovery Quality in Elderly Surgical Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06392308
• Other study ID #: 2023-K213-01
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Affiliated Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. However, the underlying mechanisms of its onset are not yet fully understood. Evidence suggests that smoking can lead to gut microbiota dysbiosis and metabolic dysfunction, and the gut microbiota and its metabolites play a crucial role in cognitive function through the gut-brain axis. Yet, no studies have reported whether smoking could affect the occurrence of postoperative delirium and the quality of postoperative recovery through the gut microbiota. This study aims to observe the incidence of postoperative delirium and the postoperative recovery quality scores between smokers and non-smokers.

Description:

After obtaining approval from the ethics committee, patients are recruited, informed of the trial process and potential risks, and their informed consent is obtained and signed. According to the WHO definition, patients are classified into smokers (defined as those who smoke more than one cigarette per day continuously or cumulatively for six months; more than four times a week but averaging less than one cigarette per day) and non-smokers (never smoked). Fecal and blood samples are collected from both groups of patients preoperatively, and perioperative data is gathered. Postoperatively, an uninformed observer assesses the patients for delirium and recovery quality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 121
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age >60 years;

• American Society of Anesthesiologists (ASA) preoperative anesthesia classification ASA Grades I and II;

• Undergoing elective surgery;

• Patients and their families are able to understand and complete various scoring scales and voluntarily sign informed consent.

Exclusion Criteria:

• Mini-Mental State Examination (MMSE) score <23;

• Preoperative biochemical tests indicate renal dysfunction or active liver disease;

• History of definite neurological or psychiatric disorders or history of taking corresponding medications before surgery;

• History of alcohol abuse or drug dependency;

• Taking antidepressant medications;

• American Society of Anesthesiologists (ASA) preoperative anesthesia classification > Grade II.

Related Conditions & MeSH terms

• Delirium
• Delirium, Postoperative

Intervention

Other:
• none intervention
No interventions are administered to either group of patients.

Locations

Country	Name	City	State
China	Affiliated hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium	CAM method	Within 3 days post-surgery
Primary	Quality of recovery in the first postoperative day	Quality of recovery is assessed with the Quality of Recovery-15 questionaire in the first postoperative day.	Up to 24 hours after surgery.