The Impact of Smoking on the Prognosis of Elderly Surgical Patients

NCT ID: NCT06392308

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Delirium, Postoperative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Smoker group

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

none intervention

Intervention Type: OTHER

No interventions are administered to either group of patients.

Non-smoker group

never smoke

none intervention

Intervention Type: OTHER

No interventions are administered to either group of patients.

Interventions

none intervention

No interventions are administered to either group of patients.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Chaochao Zhong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao-Chao Zhong

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Nantong University

Locations

Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Countries

China

Central Contacts

Chao-Chao Zhong, M.D.;P.H.D

Role: CONTACT

zhong249767626@163.com

+8615152460489

Other Identifiers

2023-K213-01

Identifier Type: -

Identifier Source: org_study_id