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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative hunger | 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 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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elderly patients undergoing thoracoscopic lung cancer radical surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Lin | Contact | +8618518134145 | 117806006@qq.com | |
| Zhong Meng Lai | Contact | +8613395000771 | zl7mg@fjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Nan Lin | Fujian Medical University Union Hospital | Principal Investigator |
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The way of sharing IPD：ResMan, http://www.medresman.org.cn/login.aspx
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Perioperative thirst |
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) |
| 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 | Closely observe whether the patient has reflux or aspiration | During the operation and 3 days after the operation |
| The incidence of perioperative nausea and vomiting | Record the frequency and severity of nausea and vomiting | During the operation and 3 days after the operation |
| C-reactive protein | The fasting venous blood of the patients was collected and detected by immunoturbidimetry. | on the early morning of the day before the operation,the first day and the third day after operation |
| Tumor necrosis factor -α | The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA). | on the early morning of the day before the operation,the first day and the third day after operation |
| Interleukin-6 | The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA). | on the early morning of the day before the operation,the first day and the third day after operation |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |