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

Official title

Effects of Different Preoperative Oral Rehydration Protocols on Safety, Comfort, and Postoperative Outcomes in Elderly Patients Undergoing Thoracoscopic Radical Lung Cancer Surgery: A Randomized Controlled Trial

Overview

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.

Detailed 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.

Primary outcome measures

• postoperative delirium [Time frame: One to three days after the operation]
• preoperative anxiety [Time frame: One day before the operation and in the morning of the operation]
• The amount of fluid in the stomach [Time frame: 2 hours before the operation, 1 hour before the operation, and before anesthesia induction]
• insulin resistance [Time frame: on the early morning of the day before the operation,the first day and the third day after operation]

Secondary outcome measures (7)

• Perioperative hunger [Time frame: 2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation]
• Perioperative thirst [Time frame: 2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation]
• The incidence of reflux aspiration during the perioperative period [Time frame: During the operation and 3 days after the operation]
• The incidence of perioperative nausea and vomiting [Time frame: During the operation and 3 days after the operation]
• C-reactive protein [Time frame: on the early morning of the day before the operation,the first day and the third day after operation]
• Tumor necrosis factor -α [Time frame: on the early morning of the day before the operation,the first day and the third day after operation]
• Interleukin-6 [Time frame: on the early morning of the day before the operation,the first day and the third day after operation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07042503 · fish77033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗