RecruitingNot ApplicableNCT05679661

Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial

Sponsor

Huang YuGuang

Enrollment

590 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Postoperative Complications

Summary

Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.

Eligibility

Min Age: 65 Years

Inclusion Criteria6

age≥65 years;
undergoing non-cardiac surgery (expected duration >2 hours);
scheduled for general anesthesia and endotracheal intubation;
ASA classification I-IV;
with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);
inform consent obtained

Exclusion Criteria5

emergency surgery;
preoperative pneumonia;
allergic to chlorhexidine;
severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
expected intervention of immunonutrition<3 days.

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Interventions

DIETARY_SUPPLEMENTimmunonutrition

Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.

BEHAVIORALoral chlorhexidine decontamination

Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.