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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07042503
Enrollment
420
Registered
2025-06-29
Start date
2025-07-01
Completion date
2026-07-01
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative deliriumOne to three days after the operationThe 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.
preoperative anxietyOne day before the operation and in the morning of the operationThe 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.
The amount of fluid in the stomach2 hours before the operation, 1 hour before the operation, and before anesthesia inductionUltrasound examination of the cross-sectional area of the antrum of the stomach
insulin resistanceon the early morning of the day before the operation,the first day and the third day after operationvenous 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

MeasureTime frameDescription
The incidence of perioperative nausea and vomitingDuring the operation and 3 days after the operationRecord the frequency and severity of nausea and vomiting
Tumor necrosis factor -αon the early morning of the day before the operation,the first day and the third day after operationThe fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).
Interleukin-6on the early morning of the day before the operation,the first day and the third day after operationThe fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).
C-reactive proteinon the early morning of the day before the operation,the first day and the third day after operationThe fasting venous blood of the patients was collected and detected by immunoturbidimetry.
Perioperative hunger2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operationThe 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)
Perioperative thirst2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operationThe 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)
The incidence of reflux aspiration during the perioperative periodDuring the operation and 3 days after the operationClosely observe whether the patient has reflux or aspiration

Contacts

Primary ContactNan Lin
117806006@qq.com+8618518134145
Backup ContactZhong Meng Lai
zl7mg@fjmu.edu.cn+8613395000771

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026