The Impact of Smoking on the Prognosis of Elderly Surgical Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium, Postoperative
• Intervention / Treatment: Other: none intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 121

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No interventions are administered to either group of patients.
Non-smoker group; never smoke	Other: none intervention; No interventions are administered to either group of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Postoperative delirium	CAM method	Within 3 days post-surgery

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Estimated): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2023-K213-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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