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

NCT07042503 | Not Yet Recruiting DMC

• 1 other identifier: fish77033
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Delirium

Keywords

preoperative oral rehydration protocol; Postoperative delirium; insulin resistance; gastric emptying status; preoperative anxiety

Outcome Measures

Primary Outcomes (4)

• postoperative delirium

  The Confusion Assessment Method - Short Form(CAM-S) scoring for postoperative delirium is as follows: Total score 20 points, 0-6 points :Mild delirium; 7-12 points:Moderate delirium; ≥13 points: Severe delirium.

  One to three days after the operation

• preoperative anxiety

  The Generalized Anxiety Disorder-7 (GAD-7) scale for preoperative anxiety assessment is as follows:Total score: 21 points，0-4 points: Normal，5-9 points: Mild anxiety，10-14 points: Moderate anxiety，≥15 points: Severe anxiety.

  One day before the operation and in the morning of the operation

• The amount of fluid in the stomach

  Ultrasound examination of the cross-sectional area of the antrum of the stomach

  2 hours before the operation, 1 hour before the operation, and before anesthesia induction

• insulin resistance

  venous blood was collected from the patients to detect fasting plasma glucose (FPG), insulin (FINS), and homeostasis model assessment of insulin resistance index (HOMA-IR).

  on the early morning of the day before the operation,the first day and the third day after operation

Secondary Outcomes (7)

• Perioperative hunger

  2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation

• Perioperative thirst

  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

  During the operation and 3 days after the operation

• The incidence of perioperative nausea and vomiting

  During the operation and 3 days after the operation

• C-reactive protein

  on the early morning of the day before the operation,the first day and the third day after operation

Study Arms (3)

Control Arm

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

Intervention Arm 1

Hourly Preoperative Ingestion of 50-100 mL clear water

Intervention Arm 2

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

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

elderly patients undergoing thoracoscopic lung cancer radical surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Conditions

Emergence Delirium; Insulin Resistance

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; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nan Lin

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Lin

CONTACT

+8618518134145; 117806006@qq.com

Zhong Meng Lai

CONTACT

+8613395000771; zl7mg@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06