Effects of Different Preoperative Oral Rehydration Protocols in Undergoing Thoracoscopic Radical Lung Cancer Surgery

Fujian Medical University (FJMU)

Status: Not yet enrolling

Conditions: Postoperative Delirium

Study type: Observational

Funder types: Other

Identifiers

NCT07042503

fish77033

Details and patient eligibility

About

This study aims to compare the new preoperative oral rehydration protocol (administering 50-100 mL of clear fluids or carbohydrate-rich beverages orally every hour until the patient arrives at the operating room) with the traditional preoperative protocol (consuming 200-300 mL of water orally two hours prior to surgery). The objective is to investigate the effects of these two protocols on the safety (e.g., risk of reflux and aspiration), comfort (e.g., levels of hunger, thirst, and anxiety), gastric emptying status (as assessed by gastric ultrasound indicators), and postoperative outcomes (e.g., incidence of postoperative delirium, insulin resistance, and inflammatory factor levels) in elderly patients undergoing thoracoscopic lung cancer radical surgery. This research seeks to identify a more appropriate preoperative rehydration protocol for elderly lung cancer patients.

Full description

This study employed a randomized controlled double-blind trial, including 420 elderly patients (aged 65 and above) who were scheduled to undergo thoracoscopic lung cancer radical surgery. The efficacy of three preoperative oral rehydration regimens was compared. The control group orally consumed 200-300ml of clear water 2 hours before the operation; the intervention group 1 orally consumed 50-100ml of clear water every hour before the operation; the intervention group 2 orally consumed 50-100ml of 12.5% carbohydrate beverages every hour before the operation, all requiring to be consumed slowly within 10-15 minutes. The evaluation indicators included: safety (intraoperative reflux aspiration, postoperative nausea and vomiting, incision and pulmonary infection rates), gastric ultrasound (amount of fluid in the stomach and emptying time), comfort (VAS for assessing hunger and thirst, SAS for assessing anxiety), postoperative delirium (CAM scale combined with electroencephalogram), insulin resistance (FPG, FINS, and HOMA-IR), and inflammatory factors (Interleukin-6, Tumor necrosis factor -α, C-reactive protein). The research data were analyzed using SPSS software to clarify the impact of different rehydration regimens on elderly patients.

Enrollment: 420 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Elderly patients aged 65 or above who are scheduled to undergo thoracoscopic radical lung cancer surgery.
2. American Society of Anesthesiologists (ASA) classification levels II-III.
3. No severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≥ 24).
4. Able to cooperate with the study and sign the informed consent form.

Exclusion criteria

1. Combined with severe functional impairments of important organs such as the heart, liver, and kidneys.
2. Suffering from metabolic diseases such as diabetes and hyperthyroidism.
3. Having digestive system diseases such as gastric emptying disorders, dysphagia, and intestinal obstruction.
4. Allergic or intolerant to carbohydrates.
5. Had received treatments such as radiotherapy and chemotherapy before the surgery that might affect the research indicators.
6. Patients with mental disorders or cognitive dysfunction.

Trial design

420 participants in 3 patient groups

Control Arm

Description:

2-hour Preoperative Ingestion of 200-300 mL clear water

Intervention Arm 1

Description:

Hourly Preoperative Ingestion of 50-100 mL clear water

Intervention Arm 2

Description:

Hourly Preoperative Ingestion of 50-100 mL 12.5% carbohydrate-containing beverages