Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-10 @ 12:40 AM
Study NCT ID:
NCT06425627
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2024-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Versus General Anesthesia on Postoperative Pulmonary Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse outcomes', 'timeFrame': 'up to one month', 'description': 'Documented side effects associated with the intervention by an unwitting third party'}], 'primaryOutcomes': [{'measure': 'Arterial partial pressure of oxygen, PaO2', 'timeFrame': '30 minutes after surgery', 'description': 'PaO2 was measured by arterial blood gas analysis'}], 'secondaryOutcomes': [{'measure': 'Arterial partial pressure of oxygen, PaO2', 'timeFrame': '30 minutes before surgery', 'description': 'PaO2 was measured by arterial blood gas analysis'}, {'measure': 'Forced vital capacity, FVC', 'timeFrame': '30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery', 'description': 'FVC was measured by Spirometer (SP70B)'}, {'measure': 'Forced expiratory volume in 1 second, FEV1', 'timeFrame': '30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery', 'description': 'FEV1 was measured by Spirometer (SP70B)'}, {'measure': 'Peak expiratory flow, PEF', 'timeFrame': '30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery', 'description': 'PEF was measured by Spirometer (SP70B)'}, {'measure': 'PEF 25, 75, and 25-75', 'timeFrame': '30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery', 'description': 'PEF 25, 75, and 25-75 were measured by Spirometer (SP70B)'}, {'measure': 'Lung Ultrasound Score (LUS)', 'timeFrame': '30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery', 'description': 'Bedside measurements using portable ultrasound'}, {'measure': 'Postoperative pulmonary complications', 'timeFrame': 'up to one month', 'description': 'Pulmonary complications (PPCs) include: (1) Evidence of pneumonia, pneumothorax, atelectasis and pleural effusion indicated by postoperative pulmonary ultrasound, chest film or chest CT; ② After surgery, the patient developed bronchospasm, ARDS, O2 requirement (nasal catheter or mask), non-invasive ventilation requirement, or unplanned endotracheal intubation/mechanical ventilation for more than 1 day; ③ The increase of inflammatory biochemical indexes 24 h after surgery suggested systemic inflammatory response (blood routine, C-reactive protein CRP, procalcitonin PCT and IL-6, IL-1β, TNF-α).'}, {'measure': 'Hip mobility (Harris hip score, HHS)', 'timeFrame': 'up to one month', 'description': 'The Harris scale was used to score. Range:0-100. A total Harris hip score below 70 points was considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip fracture', 'delayed surgery', 'pulmonary complication', 'spinal anesthesia', 'general anesthesia'], 'conditions': ['Pulmonary Complication', 'Anesthesia', 'Hip Fractures']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery.', 'detailedDescription': 'In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 65 years old\n* ASA Class I \\~ III\n* Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures\n* The time from diagnosis to surgery is more than 48 hours\n\nExclusion Criteria:\n\n* Unable to walk about 3 meters or across a room without assistance before the fracture\n* Emergency surgery\n* Congestive heart failure, asthma, anemia (Hb \\< 90 g/L), hypoalbuminemia (ALB \\< 35g/L)\n* Abnormal coagulation function\n* Severe aortic stenosis\n* Injection site infection or increased intracranial pressure\n* Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization\n* The written informed consent of the patient or his/her representative cannot be obtained'}, 'identificationModule': {'nctId': 'NCT06425627', 'briefTitle': 'Spinal Versus General Anesthesia on Postoperative Pulmonary Complications', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture', 'orgStudyIdInfo': {'id': 'TongjiHospital102114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'spinal anesthesia', 'description': 'Patients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful.', 'interventionNames': ['Procedure: spinal anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'general anesthesia', 'description': 'Rapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 \\~ 2.0% sevoflurane inhalation, remifentanil 0.1 \\~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method.', 'interventionNames': ['Procedure: general anesthesia']}], 'interventions': [{'name': 'spinal anesthesia', 'type': 'PROCEDURE', 'otherNames': ['lumbar anesthesia'], 'description': 'An intrathecal anesthetic technique.', 'armGroupLabels': ['spinal anesthesia']}, {'name': 'general anesthesia', 'type': 'PROCEDURE', 'description': 'An intravenous (combined with inhalation) anesthetic technique.', 'armGroupLabels': ['general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tianzhu Liu, M.D.', 'role': 'CONTACT', 'email': 'liutzh@126.com', 'phone': '13098866448'}, {'name': 'Tianzhu Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianzhu Liu', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Tianzhu Liu, M.D.', 'role': 'CONTACT', 'email': 'liutzh@126.com', 'phone': '13098866448'}], 'overallOfficials': [{'name': 'Tianzhu Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Tianzhu Liu', 'investigatorAffiliation': 'Tongji Hospital'}}}}