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NCT Number: NCT07042503

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

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.

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. postoperative delirium

    Time frame: One to three days after the operation

    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.

  2. preoperative anxiety

    Time frame: One day before the operation and in the morning of the operation

    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.

  3. The amount of fluid in the stomach

    Time frame: 2 hours before the operation, 1 hour before the operation, and before anesthesia induction

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

  4. insulin resistance

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

    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).

Secondary outcomes

  1. Perioperative hunger

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

    The Visual Analogue Scale (VAS) allowed patients to rate their feelings of hunger (0-10 points, 0 for no hunger and 10 for extreme hunger) and thirst (0-10 points, 0 for no thirst and 10 for extreme thirst)

  2. Perioperative thirst

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

    The Visual Analogue Scale (VAS) was used to score the sensation of thirst (on a scale of 0 to 10, where 0 indicates no sensation of thirst and 10 indicates extreme thirst)

  3. The incidence of reflux aspiration during the perioperative period

    Time frame: During the operation and 3 days after the operation

    Closely observe whether the patient has reflux or aspiration

  4. The incidence of perioperative nausea and vomiting

    Time frame: During the operation and 3 days after the operation

    Record the frequency and severity of nausea and vomiting

  5. C-reactive protein

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

    The fasting venous blood of the patients was collected and detected by immunoturbidimetry.

  6. 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

    The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).

  7. Interleukin-6

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

    The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).

Study contacts

Contact information is provided by the study sponsor or research team.

Nan Lin

CONTACT

[email protected]

+8618518134145

Zhong Meng Lai

CONTACT

[email protected]

+8613395000771

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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