Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 12:46 PM
Study NCT ID:
NCT06469866
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of recovery', 'timeFrame': '1 day after operation', 'description': 'Primary outcome measure was the quality of recovery at 1 day after surgery. Quality of recovery-15 scale was used to assess the quality of recovery after operation. A higher score of quality of recovery-15 scale indicates a better quality of recovery after surgery'}], 'secondaryOutcomes': [{'measure': 'Shoulder pain', 'timeFrame': 'The first 24 hours after operation', 'description': 'Secondary Outcome Measure was the incidence of shoulder pain'}, {'measure': 'Postoperative nausea and vomiting', 'timeFrame': 'The first 24 hours after operation', 'description': 'Secondary Outcome Measure was the incidence of postoperative nausea and vomiting. PONV score was evaluated verbally with a descriptive scale (0 = None, 1 = Mild Nausea, 2 = Moderate Nausea, 3 = One Vomiting, 4 = Multiple Vomiting).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular block', 'Recovery', 'Laparoscopic hysterectomy'], 'conditions': ['Neuromuscular Blockade', 'Laparoscopy']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy\n\nMETHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ\n* Scheduled for elective laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* BMI \\>35\n* Renal or hepatic insufficiency\n* History of preoperative psychiatric\n* Previous surgery at procedure site\n* Neuromuscular disease, pregnancy, and contraindications to study medications.'}, 'identificationModule': {'nctId': 'NCT06469866', 'briefTitle': 'Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Anqing Municipal Hospital'}, 'officialTitle': 'Effect of Deep Neuromuscular Block on the Quality of Recovery After Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': 'xuzhang520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery', 'description': 'low-pressure pneumoperitoneum (LPP) with deep NMB.', 'interventionNames': ['Device: low-pressure pneumoperitoneum', 'Device: standard-pressure pneumoperitoneum']}, {'type': 'EXPERIMENTAL', 'label': 'standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery', 'description': 'standard-pressure pneumoperitoneum (SPP) with moderate NMB.', 'interventionNames': ['Device: low-pressure pneumoperitoneum', 'Device: standard-pressure pneumoperitoneum']}], 'interventions': [{'name': 'low-pressure pneumoperitoneum', 'type': 'DEVICE', 'description': 'low-pressure pneumoperitoneum (LPP) with deep NMB.', 'armGroupLabels': ['low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery', 'standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery']}, {'name': 'standard-pressure pneumoperitoneum', 'type': 'DEVICE', 'description': 'standard-pressure pneumoperitoneum (SPP) with moderate NMB.', 'armGroupLabels': ['low-pressure pneumoperitoneum (LPP) with deep NMB affect quality of recovery', 'standard-pressure pneumoperitoneum (SPP) with moderate NMB affect quality of recovery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '246000', 'city': 'Anqing', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xu siqi', 'role': 'CONTACT', 'email': 'errtg555@163.com'}, {'role': 'CONTACT', 'phone': '13865192106'}], 'facility': 'Department of Anqing Munucipal Hospital Anesthesiology', 'geoPoint': {'lat': 30.51365, 'lon': 117.04723}}], 'centralContacts': [{'name': 'Xu si qi, Doctor', 'role': 'CONTACT', 'email': 'errtg555@163.com', 'phone': '13865192106'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anqing Municipal Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}