Ignite Creation Date:
2025-12-25 @ 3:05 AM
Ignite Modification Date:
2025-12-31 @ 6:37 PM
Study NCT ID:
NCT03782233
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2018-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study on the Level of Neuromuscular Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hh19871117@126.com', 'phone': '13852476684', 'title': 'Dr. He Huang', 'organization': 'The First Affiliated Hospital of Nanjing Medical University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'through study completion, an average of 2 weeks', 'description': 'Our definitions are consistent with the clinicaltrials.gov.', 'eventGroups': [{'id': 'EG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 0, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Concentration of D-lactic Acid Before the Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1100.4', 'spread': '156.6', 'groupId': 'OG000'}, {'value': '1087.8', 'spread': '146.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day before the surgery', 'description': 'The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day Before the Surgery', 'description': 'The level of DAO can indicate the damage to the gastrointestinal barrier .', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1695', 'groupId': 'OG000'}, {'value': '1287', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'the first time of defecation after operation', 'description': "Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform.\n\nThe raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity.\n\nHigher values represent a more abundant amount of bacteria in gut.", 'unitOfMeasure': 'units', 'reportingStatus': 'POSTED', 'populationDescription': 'There were only 8 patients in group D and 5 patients in group M defecating before discharged from hospital.'}, {'type': 'PRIMARY', 'title': 'Postoperative Exhaust Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '26.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'It is calculated from the end of the operation to the time of exhaust.', 'description': "It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust.", 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of D-lactic Acid 24 h After the Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1230.7', 'spread': '138.4', 'groupId': 'OG000'}, {'value': '1297.5', 'spread': '147.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 h after the surgery', 'description': 'The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 h after the Surgery', 'description': 'The level of DAO can indicate the damage to the gastrointestinal barrier .', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Relative Abundance of Intestinal Microbiota', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'title': 'Class-Deltaproteobacteria', 'categories': [{'measurements': [{'value': '0.0010483424321', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.0010483424321', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'Class-Flavobacteriia', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.000019780046', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Order-Desulfovibrionales', 'categories': [{'measurements': [{'value': '0.0081493789065', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0010483424321', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Order-Flavobacteriales', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.00003956', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Family-[Tissierellaceae]', 'categories': [{'measurements': [{'value': '0.0021362449560', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0001186802753', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Family-Fusobacteriaceae', 'categories': [{'measurements': [{'value': '0.0005340612390', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0196020254767', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Family-Desulfovibrionaceae', 'categories': [{'measurements': [{'value': '0.0081493789065', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0010285623862', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Family-[Weeksellaceae]', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.000019780046', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Blautia', 'categories': [{'measurements': [{'value': '0.0097021125088', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0024725057362', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Dialister', 'categories': [{'measurements': [{'value': '0.0002175805047', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0042724899121', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Collinsella', 'categories': [{'measurements': [{'value': '0.0024329456444', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Fusobacterium', 'categories': [{'measurements': [{'value': '0.0005340612390', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0196020254767', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Bilophila', 'categories': [{'measurements': [{'value': '0.0050636917477', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0010087823403', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Aggregatibacter', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0007120816520', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Megasphaera', 'categories': [{'measurements': [{'value': '0.000059340138', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.0019780045889', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Neisseria', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.000019780046', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Selenomonas', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.000039560092', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-Roseburia', 'categories': [{'measurements': [{'value': '0.000019780046', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Genus-TG5', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.000019780045', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'the first time of defecation after operation', 'description': 'Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.', 'unitOfMeasure': 'percentage of all intestinal microbiota', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital.'}, {'type': 'PRIMARY', 'title': '16s rRNA Sequencing of Postoperative Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade Group (Group D)', 'description': 'Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.\n\nA continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).: 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade Group (Group M)', 'description': 'Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.\n\nA continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).: 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'title': 'alpha diversity - Chao1', 'categories': [{'measurements': [{'value': '763.7', 'spread': '183.7', 'groupId': 'OG000'}, {'value': '599.3', 'spread': '164.0', 'groupId': 'OG001'}]}]}, {'title': 'alpha diversity - Shannon index', 'categories': [{'measurements': [{'value': '4.93', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.15', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'alpha diversity - Simpson index', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'the first time of defecation after operation', 'description': 'Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity.\n\nBata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital. There are so much basic data about the 16s rRNA sequencing that we can not upload them. The amount of work was formidable. You may contact with me if necessary for all the sequencing data.'}, {'type': 'SECONDARY', 'title': 'Duration of Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '155.0', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '174.6', 'spread': '34.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From the first dose of anesthetic to the end of the surgery', 'description': 'Time from the first dose of anesthetic to the end of the surgery', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Condition Scores Rated by Surgeons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'title': '1 point', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '2 points', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '3 points', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': '4 points', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '5 points', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During operation, within 2 hours', 'description': 'evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of CO2 Pneumoperitoneum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '132.3', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '147.0', 'spread': '34.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from the beginning to the end of CO2 pneumoperitoneum', 'description': 'Time from the beginning to the end of CO2 pneumoperitoneum', 'unitOfMeasure': 'minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Postoperative Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from the end of surgery to the time of being discharged from hospital', 'description': 'Duration from the day of surgery to the day the patient discharged from the hospital', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative VAS (12 h After Surgery, Rest State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative VAS (12 h After Surgery, Active State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative VAS (24 h After Surgery, Rest State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative VAS (24 h After Surgery, Active State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. 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A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Condition Scores Rated by Surgeons (Average Scores)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'OG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during surgery', 'description': 'evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'FG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Deep Neuromuscular Blockade（Group D）', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).'}, {'id': 'BG001', 'title': 'Moderate Neuromuscular Blockade (Group M)', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.6', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '60.0', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23.6', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '23.92', 'spread': '2.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-05', 'size': 151026, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-04T22:27', 'hasProtocol': True}, {'date': '2018-11-04', 'size': 100675, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-05T00:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2018-12-11', 'resultsFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentration of D-lactic Acid Before the Surgery', 'timeFrame': '1 day before the surgery', 'description': 'The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .'}, {'measure': 'Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery', 'timeFrame': '1 day Before the Surgery', 'description': 'The level of DAO can indicate the damage to the gastrointestinal barrier .'}, {'measure': 'Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota', 'timeFrame': 'the first time of defecation after operation', 'description': "Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform.\n\nThe raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity.\n\nHigher values represent a more abundant amount of bacteria in gut."}, {'measure': 'Postoperative Exhaust Time', 'timeFrame': 'It is calculated from the end of the operation to the time of exhaust.', 'description': "It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust."}, {'measure': 'Plasma Concentration of D-lactic Acid 24 h After the Surgery', 'timeFrame': '24 h after the surgery', 'description': 'The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .'}, {'measure': 'Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery', 'timeFrame': '24 h after the Surgery', 'description': 'The level of DAO can indicate the damage to the gastrointestinal barrier .'}, {'measure': 'Relative Abundance of Intestinal Microbiota', 'timeFrame': 'the first time of defecation after operation', 'description': 'Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.'}, {'measure': '16s rRNA Sequencing of Postoperative Feces', 'timeFrame': 'the first time of defecation after operation', 'description': 'Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity.\n\nBata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Duration of Surgery', 'timeFrame': 'From the first dose of anesthetic to the end of the surgery', 'description': 'Time from the first dose of anesthetic to the end of the surgery'}, {'measure': 'Surgical Condition Scores Rated by Surgeons', 'timeFrame': 'During operation, within 2 hours', 'description': 'evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.'}, {'measure': 'Duration of CO2 Pneumoperitoneum', 'timeFrame': 'from the beginning to the end of CO2 pneumoperitoneum', 'description': 'Time from the beginning to the end of CO2 pneumoperitoneum'}, {'measure': 'Duration of Postoperative Hospital Stay', 'timeFrame': 'from the end of surgery to the time of being discharged from hospital', 'description': 'Duration from the day of surgery to the day the patient discharged from the hospital'}, {'measure': 'Postoperative VAS (12 h After Surgery, Rest State)', 'timeFrame': '12 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.'}, {'measure': 'Postoperative VAS (12 h After Surgery, Active State)', 'timeFrame': '12 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.'}, {'measure': 'Postoperative VAS (24 h After Surgery, Rest State)', 'timeFrame': '24 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.'}, {'measure': 'Postoperative VAS (24 h After Surgery, Active State)', 'timeFrame': '24 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.'}, {'measure': 'Postoperative VAS (48 h After Surgery, Rest State)', 'timeFrame': '48 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.'}, {'measure': 'Postoperative VAS (48 h After Surgery, Active State)', 'timeFrame': '48 h after surgery', 'description': 'VAS pain score: 0 - completely painless, 10 - unbearable pain.'}, {'measure': 'Surgical Condition Scores Rated by Surgeons (Average Scores)', 'timeFrame': 'during surgery', 'description': 'evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuromuscular Blockade', 'Gastrointestinal Barrier Function'], 'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'On the basis of moderate pneumoperitoneum pressure(10 mmHg), this study evaluates the effect of different level of neuromuscular blockade to gastrointestinal barrier function during laparoscopic gastrectomy. 83 patients are randomized to 2 arms ,The patients in deep neuromuscular blockade group（group D, PTC=1-2）will receive high dose rocuronium (0.5-0.6 mg/kg/h) ;While the patients in moderate neuromuscular blockade group（group M, TOF=1-2）will receive moderate dose rocuronium (0.2-0.3 mg/kg/h)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:40-80;\n2. BMI \\< 30kg/m2；\n3. ASA classification:Ⅰ-Ⅲ；\n4. Undergoing elective laparoscopic gastrectomy.\n\nExclusion Criteria:\n\n1. Preoperative history of inflammatory intestinal diseases, intestinal flora disorders, obstructive jaundice, intestinal obstruction, irritable bowel syndrome and other digestive diseases;\n2. Severe heart, lung, liver, kidney, brain and other diseases;\n3. Serious infection, pancreatitis, burns, trauma, need a large dose, long-term use of antibiotics before the operation;\n4. A history of abdominal surgery;\n5. Combined with gravis myasthenia, serious electrolyte disorders or neuromuscular diseases.'}, 'identificationModule': {'nctId': 'NCT03782233', 'briefTitle': 'Study on the Level of Neuromuscular Blockade', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate Neuromuscular Blockade.', 'orgStudyIdInfo': {'id': 'He Huang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'deep neuromuscular blockade group (Group D)', 'description': 'Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.', 'interventionNames': ['Drug: A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).']}, {'type': 'OTHER', 'label': 'moderate neuromuscular blockade group (Group M)', 'description': 'Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.', 'interventionNames': ['Drug: A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).']}], 'interventions': [{'name': 'A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).', 'type': 'DRUG', 'description': '50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).', 'armGroupLabels': ['deep neuromuscular blockade group (Group D)']}, {'name': 'A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).', 'type': 'DRUG', 'description': '33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).', 'armGroupLabels': ['moderate neuromuscular blockade group (Group M)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital with Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wu Jieping Medical Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}