Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 7:04 PM
Study NCT ID:
NCT07042503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Preoperative Oral Rehydration Protocols in Undergoing Thoracoscopic Radical Lung Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071257', 'term': 'Emergence Delirium'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}, 'targetDuration': '4 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2025-06-16', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative delirium', 'timeFrame': 'One to three days after the operation', 'description': 'The Confusion Assessment Method - Short Form(CAM-S) scoring for postoperative delirium is as follows:\n\nTotal score 20 points, 0-6 points :Mild delirium; 7-12 points:Moderate delirium;\n\n≥13 points: Severe delirium.'}, {'measure': 'preoperative anxiety', 'timeFrame': 'One day before the operation and in the morning of the operation', 'description': '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.'}, {'measure': 'The amount of fluid in the stomach', 'timeFrame': '2 hours before the operation, 1 hour before the operation, and before anesthesia induction', 'description': 'Ultrasound examination of the cross-sectional area of the antrum of the stomach'}, {'measure': 'insulin resistance', 'timeFrame': 'on the early morning of the day before the operation,the first day and the third day after operation', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Perioperative hunger', 'timeFrame': '2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation', 'description': '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)'}, {'measure': 'Perioperative thirst', 'timeFrame': '2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation', 'description': '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)'}, {'measure': 'The incidence of reflux aspiration during the perioperative period', 'timeFrame': 'During the operation and 3 days after the operation', 'description': 'Closely observe whether the patient has reflux or aspiration'}, {'measure': 'The incidence of perioperative nausea and vomiting', 'timeFrame': 'During the operation and 3 days after the operation', 'description': 'Record the frequency and severity of nausea and vomiting'}, {'measure': 'C-reactive protein', 'timeFrame': 'on the early morning of the day before the operation,the first day and the third day after operation', 'description': 'The fasting venous blood of the patients was collected and detected by immunoturbidimetry.'}, {'measure': 'Tumor necrosis factor -α', 'timeFrame': 'on the early morning of the day before the operation,the first day and the third day after operation', 'description': 'The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).'}, {'measure': 'Interleukin-6', 'timeFrame': 'on the early morning of the day before the operation,the first day and the third day after operation', 'description': 'The fasting venous blood of the patients was collected and detected by enzyme-linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative oral rehydration protocol', 'Postoperative delirium', 'insulin resistance', 'gastric emptying status', 'preoperative anxiety'], 'conditions': ['Postoperative Delirium']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'elderly patients undergoing thoracoscopic lung cancer radical surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elderly patients aged 65 or above who are scheduled to undergo thoracoscopic radical lung cancer surgery.\n2. American Society of Anesthesiologists (ASA) classification levels II-III.\n3. No severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≥ 24).\n4. Able to cooperate with the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Combined with severe functional impairments of important organs such as the heart, liver, and kidneys.\n2. Suffering from metabolic diseases such as diabetes and hyperthyroidism.\n3. Having digestive system diseases such as gastric emptying disorders, dysphagia, and intestinal obstruction.\n4. Allergic or intolerant to carbohydrates.\n5. Had received treatments such as radiotherapy and chemotherapy before the surgery that might affect the research indicators.\n6. Patients with mental disorders or cognitive dysfunction.'}, 'identificationModule': {'nctId': 'NCT07042503', 'briefTitle': 'Effects of Different Preoperative Oral Rehydration Protocols in Undergoing Thoracoscopic Radical Lung Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University Union Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'fish77033'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Arm', 'description': '2-hour Preoperative Ingestion of 200-300 mL clear water'}, {'label': 'Intervention Arm 1', 'description': 'Hourly Preoperative Ingestion of 50-100 mL clear water'}, {'label': 'Intervention Arm 2', 'description': 'Hourly Preoperative Ingestion of 50-100 mL 12.5% carbohydrate-containing beverages'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nan Lin', 'role': 'CONTACT', 'email': '117806006@qq.com', 'phone': '+8618518134145'}, {'name': 'Zhong Meng Lai', 'role': 'CONTACT', 'email': 'zl7mg@fjmu.edu.cn', 'phone': '+8613395000771'}], 'overallOfficials': [{'name': 'Nan Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The way of sharing IPD：ResMan, http://www.medresman.org.cn/login.aspx'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}