Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT05391958
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2022-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2022-05-07', 'studyFirstSubmitQcDate': '2022-05-22', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in average dosing interval time', 'timeFrame': 'during the surgery', 'description': 'PTC(post-tetanic count)was measured every 6min during the operation, and cisatracurium was injected once when PTC \\> 2,average dosing interval time was recorded'}, {'measure': 'Change in Times of adding cisatracurium', 'timeFrame': 'during the surgery', 'description': 'PTC was measured every 6min during the operation, and cisatracurium was injected once when PTC \\> 2,and recording the total times of injection.'}, {'measure': 'Change in total dosage of cisatracurium', 'timeFrame': 'during the surgery', 'description': 'PTC(post-tetanic count) was measured every 6min during the operation, and cisatracurium was injected once when PTC \\> 2,and recording the total dosage of total dosage of cisatracurium'}, {'measure': 'Change in time of onset', 'timeFrame': 'through study completion, an average of 3 minute after induction', 'description': '0.15mg/kg (3ED95) cisatracurium was given to all groups according to actual body weight as induction dose. Tracheal intubation was performed in all groups when TOFr(train of four ratio)=0.recording the time during this process.'}, {'measure': 'Change in TOF(train of four) recovered to 0.7 and 0.9 from the last injection', 'timeFrame': 'up to 1 hour after the surgery', 'description': 'The recovery of TOF(train of four) was continue observed after surgery.Recording the time both when TOF(train of four) recovered to 0.7 and 0.9'}, {'measure': 'Change in time during PACU(postanesthesia care unit)', 'timeFrame': 'up to 2 hour after the surgery', 'description': 'recoding the duration of stay in PACU(postanesthesia care unit)'}, {'measure': 'surgical rating scale(SRS)', 'timeFrame': 'during the surgery', 'description': 'Surgical rating Scale (SRS) was evaluated by surgical surgeons at the beginning, 1h and 2h of surgery, with a range of 1 to 5, corresponding to "extremely poor", "poor", "adequate", "good" and "best".'}], 'secondaryOutcomes': [{'measure': 'The change of MAP (mean arterial pressure)', 'timeFrame': 'immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection', 'description': 'Mean arterial pressure were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection'}, {'measure': 'The change of HR(heart rate)', 'timeFrame': 'immediately , 10 minutes , 20 minutes , 30 minutes and 40 min later after the first injection', 'description': 'the heart rate were recorded immediately , 10 minutes , 20 minutes , 30 minutes , and 40 minutes later after the first injection'}, {'measure': 'Change in PaCO2 before and after pneumoperitoneum', 'timeFrame': 'before and after pneumoperitoneum during the surgery', 'description': 'arterial blood gas(ABG) was measured before and after pneumoperitoneum.Recording PaCO2 before and after pneumoperitoneum'}, {'measure': 'Incidence of postoperative pain', 'timeFrame': 'Immediately after surgery and One day after surgery', 'description': 'Incidence of postoperative pain (shoulder, lumbar abdomen, arm)'}, {'measure': 'Whether hypoxemia occurs after extubation', 'timeFrame': 'within 10 minutes after extubation', 'description': 'Observe the occurrence of hypoxemia after extubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Cisatracurium', 'Obesity', 'Neuromuscular Blockade', 'Pneumoperitoneum', 'Pharmacology'], 'conditions': ['Obese Patients', 'Laparoscopic Colorectal Surgery']}, 'descriptionModule': {'briefSummary': 'To observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal surgery', 'detailedDescription': "According to the random number table method, one hundred and twenty patients who underwent elective laparoscopic colorectal surgery were divided into four groups (n=30): Normal weight patients according to lean body weight group(NL group), normal weight patients according to real weight group (NR group), obese patients according to lean body weight group(OL group), and obese patients according to real weight group(OR group).Intraoperative deep neuromuscular blockade (PTC≤2)was maintained in all four groups.The dosage of cisatracurium, the number of injections,time to effect,time to recovery from TOFr,time to recover TOFr（train-of-four rate） to 0.7 and 0.9,and time to stay in PCAU were recorded.The surgeon's satisfaction with the operative field and the average intraoperative pneumoperitoneum pressure were recorded at the time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum establishment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laparoscopic Colorectal Surgery\n* American Society of Anesthesiologists (ASA) grades I-III\n\nExclusion Criteria:\n\n* Patients with heart, lung and other vital organ disorders\n* Preoperative fluid and electrolyte disturbance\n* Preoperative water and electrolyte disorders have a history of neuromuscular disease or take medications that have an impact on neuromuscular function\n* There is a significant airway difficulty\n* Refuse to sign informed consent'}, 'identificationModule': {'nctId': 'NCT05391958', 'briefTitle': 'Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The First Hospital of Qinhuangdao'}, 'officialTitle': 'Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients', 'orgStudyIdInfo': {'id': '070733'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Normal Real group', 'description': 'the medication group was given according to the actual weight of normal weight patients', 'interventionNames': ['Behavioral: base on Actual Body Weight', 'Genetic: normal patients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Lean group', 'description': 'For normal weight patients, the medication group was given according to the lean body mass', 'interventionNames': ['Behavioral: base on Lean Body Mass Pattern', 'Genetic: normal patients']}, {'type': 'SHAM_COMPARATOR', 'label': 'Obese Real group', 'description': 'the medication group was given according to the actual weight of obese weight patients', 'interventionNames': ['Behavioral: base on Actual Body Weight', 'Genetic: obese patients']}, {'type': 'EXPERIMENTAL', 'label': 'Obese Lean group', 'description': 'the medication group was given according to the lean body mass of obese weight patients', 'interventionNames': ['Behavioral: base on Lean Body Mass Pattern', 'Genetic: obese patients']}], 'interventions': [{'name': 'base on Lean Body Mass Pattern', 'type': 'BEHAVIORAL', 'otherNames': ['general anesthesia'], 'description': 'PTC(post-tetanic count) was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on lean body weight mass pattern once when PTC \\> 2.', 'armGroupLabels': ['Normal Lean group', 'Obese Lean group']}, {'name': 'base on Actual Body Weight', 'type': 'BEHAVIORAL', 'otherNames': ['base on Actual Body Mass Pattern'], 'description': 'PTC was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on actual body weight once when PTC \\> 2.', 'armGroupLabels': ['Normal Real group', 'Obese Real group']}, {'name': 'obese patients', 'type': 'GENETIC', 'otherNames': ['laparoscopic colorectal surgery'], 'description': 'obese patients with elective laparoscopic colorectal surgery were selected，and the inclusion criteria were as follows: age 18-65, body mass index (BMI) 30-35, waist circumference (WC) : female ≥80cm, male ≥90cm, and American Society of Anesthesiologists (ASA) grade Ⅰ \\~ Ⅲ.', 'armGroupLabels': ['Obese Lean group', 'Obese Real group']}, {'name': 'normal patients', 'type': 'GENETIC', 'otherNames': ['laparoscopic colorectal surgery'], 'description': 'normal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ \\~ Ⅲ.', 'armGroupLabels': ['Normal Lean group', 'Normal Real group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qinhuangdao', 'country': 'China', 'facility': 'The First hosptial of Qinhuangdao', 'geoPoint': {'lat': 39.94104, 'lon': 119.58936}}], 'overallOfficials': [{'name': 'PI qinshuang liu, master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First hosptial of Qinhuangdao'}, {'name': 'yuli guo, master', 'role': 'STUDY_CHAIR', 'affiliation': 'The First hosptial of Qinhuangdao'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Qinhuangdao', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}