Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT05582356
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2022-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery-15 score', 'timeFrame': 'Postoperative 24th hour', 'description': 'Minimum value: 0, Maximum value: 150, higher scores mean better.'}], 'secondaryOutcomes': [{'measure': 'Quality of Recovery-15 score', 'timeFrame': 'preoperative, postoperative day 7', 'description': 'Minimum value: 0, Maximum value: 150, higher scores mean better.'}, {'measure': 'Numerical Rating Scale', 'timeFrame': '24 hours', 'description': 'Range 0-10, 0=no pain, 10=the worse pain ever.'}, {'measure': 'Opioid consumption', 'timeFrame': '24 hours', 'description': 'Opioid consumption'}, {'measure': 'Range of knee motion', 'timeFrame': '48 hours', 'description': 'Range of knee motion'}, {'measure': 'Patient mobilization', 'timeFrame': '48 hours', 'description': 'Patient reporting time of first standing to the side of the bed and time up and go test 2 days'}, {'measure': 'Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission', 'timeFrame': 'preoperative', 'description': '5: very satisfied, 4: somewhat satisfied, 3: neutral, 2: somewhat dissatisfied, 1: very dissatisfied'}, {'measure': 'Mini Mental State Examination', 'timeFrame': 'preoperative and postoperatve day 1', 'description': 'Mini Mental State Examination Scale (This scale is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.)'}, {'measure': 'Sleep Quality measured with Likert Scale', 'timeFrame': 'One week after surgery', 'description': "Patients' perceived sleep quality will be assessed with a Likert scale. Likert scale is scored from Likert scale where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied"}, {'measure': 'Glucose measurement', 'timeFrame': 'Postoperative 24th hour', 'description': 'Glucose measurement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Carbohydrate', 'Elderly Patient', 'Mini Mental State Examination'], 'conditions': ['Quality Of Recovery']}, 'descriptionModule': {'briefSummary': "This prospective randomized controlled study will be aimed to evaluate the effect of preoperative oral carbohydrate loading on the elderly patient's quality of recovery and satisfaction in undergoing knee arthroplasty (TKA) surgery with spinal anesthesia.", 'detailedDescription': "As an essential aspect of enhanced recovery after surgery, the advantages of preoperative oral carbohydrate loading (eg, improving patients' comfort during preoperative preparation, reducing nausea and vomiting, and reducing insulin resistance) have been shown by a large number of studies.\n\nThis study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Elderly ( \\> 65) patients scheduled for elective TKA will be screened for enrollment in the study. Patients will be randomized into an oral carbohydrate group (Group OC), and an oral placebo group (Group OP). Solid food will be forbidden starting at 20:00, and drinking will be banned after 22:00 the day before surgery. Oral carbohydrate preload will be administered to the Group OC. In Group OP, the blinded researcher will give an equal volume of placebo fluid orally at 22:00 and 2 hours before the operation in the ward. The participant will record that the liquid has been completely consumed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physical status according to the American Society of Anesthesiologists (ASA) I-III\n* Patients scheduled for total knee arthroplasty\n\nExclusion Criteria:\n\n* Previous operation on same knee\n* Hepatic or renal insufficiency\n* Younger than 65 years old\n* Patients undergoing general anesthesia\n* Allergy or intolerance to one of the study medications\n* ASA IV\n* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)\n* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \\>5mg/day for one month)\n* impaired gastrointestinal motility\n* Fasting glucose \\>200\n* Acquired immunodeficiency\n* Severe malnutrition'}, 'identificationModule': {'nctId': 'NCT05582356', 'briefTitle': 'Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Karaman Training and Research Hospital'}, 'officialTitle': 'Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '08-2023/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbohydrate group (Group OC)', 'description': 'Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. Group OC will consume carbohydrate fluid at 22.00 p.m. and two hours before the surgery', 'interventionNames': ['Dietary Supplement: Carbohydrate group (Group OC)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo group (Group OP)', 'description': 'Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. Group OP will consume an equal amount of water 22:00 p.m. and two hours before the surgery.', 'interventionNames': ['Dietary Supplement: Placebo group (Group OP']}], 'interventions': [{'name': 'Carbohydrate group (Group OC)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Carbohydrate group (Group OC)', 'armGroupLabels': ['Carbohydrate group (Group OC)']}, {'name': 'Placebo group (Group OP', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo group (Group OP', 'armGroupLabels': ['Placebo group (Group OP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'country': 'Turkey (Türkiye)', 'facility': 'Karaman Training and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'overallOfficials': [{'name': 'Betül Başaran, MD,DESA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karaman Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}