The Impact of Smoking on the Prognosis of Elderly Surgical Patients

NCT06392308 | Not Yet Recruiting

• 1 other identifier: 2023-K213-01
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium, Postoperative

Outcome Measures

Primary Outcomes (2)

• Postoperative delirium

  CAM method

  Within 3 days post-surgery

• 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.

Study Arms (2)

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

Other: none intervention

Non-smoker group

never smoke

Other: none intervention

Interventions

none intervention OTHER

No interventions are administered to either group of patients.

Non-smoker group; Smoker group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients who meet the inclusion criteria are divided into a smoking group and a non-smoking group based on their smoking status. The general information of the patients, perioperative data, and postoperative follow-up data are recorded. By conducting propensity score matching analysis, differences in outcomes due to confounding factors are minimized, and exploratory analysis is performed on the matched patient data to investigate the impact of gut microbiota and metabolism on the incidence of postoperative delirium and the quality of postoperative recovery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Chao-Chao Zhong

  Affiliated Hospital of Nantong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+8615152460489; zhong249767626@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)