Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 1:37 PM
Study NCT ID:
NCT04814706
Status:
COMPLETED
Last Update Posted:
2022-07-05
First Post:
2021-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-01', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric volume 1', 'timeFrame': 'First stage operation, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes', 'description': 'Gastric volume measured before induction of spinal anesthesia using ultrasound'}, {'measure': 'Gastric volume 2', 'timeFrame': 'Second stage operative, during the gastric volume measuring at preoperative holding area/ an average of 30 minutes', 'description': 'Gastric volume measured before induction of spinal anesthesia using ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Knee']}, 'descriptionModule': {'briefSummary': 'In the past, some guidelines advised no oral intake for at least 8 hours before any surgery, However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.\n\nThe perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.\n\nSome factors have been known to influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.\n\nIn the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.\n\nIn the present study, the investigators will evaluate the effect of old age, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants will be patients whom are scheduled to undergo staged bilateral total knee arthroplasty requiring administration of carbohydrate-containing fluid 2 hours prior to surgery.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years\n* American Society of Anesthesiologists physical status classification 1, 2, and 3\n* Body mass index \\< 35 kg/cm2\n* Patients administered carbohydrate-containing fluid 2 hours prior to surgery\n\nExclusion Criteria:\n\n* Previous surgery of the upper gastrointestinal tract\n* Achalasia\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT04814706', 'briefTitle': 'Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Ultrasound Assessment of Gastric Volume in Elderly Patients Undergoing Staged-bilateral Total Knee Arthroplasty After Drinking Carbohydrate-containing Fluids: A Prospective Observational Comparative Study', 'orgStudyIdInfo': {'id': 'B-2103/673-302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group C', 'description': 'Patients drank carbohydrate fluid 2 hours prior to surgery.', 'interventionNames': ['Dietary Supplement: Carbohydrate drinking']}], 'interventions': [{'name': 'Carbohydrate drinking', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Administration of carbohydrate fluid', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}