Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05891951
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2023-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'In this study, researchers and subjects were not blind. Anesthesiologists and data collectors were blind. Researchers conducted carotid ultrasound guided fluid therapy for experimental groups according to the groups, anesthesiologists performed routine induction for patients in the two groups, data collectors collected data, and anesthesiologists and data collectors did not know the groups of subjects.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized controlled clinical study to investigate whether carotid ultrasound-guided fluid therapy reduces the incidence of induced hypotension in elderly patients undergoing gastrointestinal surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2023-05-28', 'studyFirstSubmitQcDate': '2023-05-28', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of hypotension after anesthesia induction', 'timeFrame': 'General anesthesia induction from the beginning to 20 minutes after induction', 'description': 'Hypotension occurred from anesthesia induction to 20 minutes after induction in both groups.'}], 'secondaryOutcomes': [{'measure': 'Postoperative acute kidney injury', 'timeFrame': 'Within 7 days after surgery', 'description': 'Postoperative creatinine increased for a short period of time to more than 0.3mg/dl (26.5μmol/L) or to more than 1.5 times the preoperative creatinine concentration.'}, {'measure': 'postoperative delirium', 'timeFrame': 'Within 30 days after surgery', 'description': 'Newly diagnosed delirium by the psychiatric department within 30 days after surgery'}, {'measure': 'postoperative stroke', 'timeFrame': 'Within 30 days after surgery', 'description': 'Any newly diagnosed postoperative neurological dysfunction within 30 days after surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension on Induction']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery.\n\nThe main question\\[s\\] it aims to answer are:\n\nWhether fluid therapy reduces the incidence of general anaesthesia induced hypotension in elderly patients undergoing gastrointestinal surgery.\n\nWhether carotid ultrasound can guide fluid management in elderly patients undergoing gastrointestinal surgery.\n\nParticipants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. There is a comparison group: No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 60-80 years old\n* gender unlimited\n* ASA: Grade I-Ⅲ\n* BMI:18-30kg/㎡\n* Patients undergoing elective gastrointestinal surgery under general anesthesia Informed consent\n\nExclusion Criteria:\n\n* Carotid artery stenosis ≥50%\n* Patients with heart valve disease\n* Patients with left ventricular ejection fraction \\< 50%\n* Patients with cardiac dysfunction (NYHA grade Ⅲ-Ⅳ and/or NTproBNP≥900pg/ml)\n* Patients Combined with renal insufficiency (creatinine ≥178μmol/L, and/or blood urea nitrogen \\> 9mmol/L)\n* Preoperative systolic blood pressure\\> 160mmHg or diastolic blood pressure \\> 100mmHg\n* Refuse to participate in the test\n* Patients participating in other clinical trials'}, 'identificationModule': {'nctId': 'NCT05891951', 'briefTitle': 'Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery', 'orgStudyIdInfo': {'id': '2023197'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B-Carotid ultrasound guided fluid therapy', 'description': 'Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced.', 'interventionNames': ['Other: Fluid therapy under the guide of Carotid ultrasound']}, {'type': 'NO_INTERVENTION', 'label': 'C-No intervention', 'description': 'No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.'}], 'interventions': [{'name': 'Fluid therapy under the guide of Carotid ultrasound', 'type': 'OTHER', 'description': 'Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient. If volume is sufficient, no fluid therapy will be given.', 'armGroupLabels': ['B-Carotid ultrasound guided fluid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jingfeng Bai, master', 'role': 'CONTACT', 'email': 'bjf159323@163.com', 'phone': '+8615773490489'}], 'facility': 'China,Chongqing The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Jingfeng Bai', 'role': 'CONTACT', 'email': 'bjf159323@163.com', 'phone': '15773490489'}], 'overallOfficials': [{'name': 'Su Min', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Min Su', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director,Principal Investigator, Clinical Professor', 'investigatorFullName': 'Min Su', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}