Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 3:45 AM
Study NCT ID:
NCT06553066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'in the assessment of the surgical field quality surgeons are blind respect the level of neuromuscular block received by patients'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-10', 'studyFirstSubmitDate': '2024-07-04', 'studyFirstSubmitQcDate': '2024-08-10', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'impact of a deep neuromuscular blockade on surgical conditions', 'timeFrame': 'During surgery', 'description': 'impact of a deep neuromuscular blockade (TOF count = 0 and posttetanic count \\[PTC\\] 1-2) and a moderate neuromuscular blockade (TOF count= 1 - 3) on intraoperative surgical conditions assessed by the surgeon as a 5 points scale'}], 'secondaryOutcomes': [{'measure': 'the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.', 'timeFrame': 'in the first six postoperative hours', 'description': 'quantitatively using chest computed tomography and expressed as percentage to total lung tissue volume'}, {'measure': 'Postoperative pain', 'timeFrame': 'first postoperative day', 'description': 'Pain was measured four times in the PACU (at 15 min intervals starting upon arrival) and twice on the ward (8PM the day of surgery and 2 PM the next day).Pain was measured using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (most pain imaginable).'}, {'measure': 'Mean arterial pressure (mmHg)', 'timeFrame': 'intraoperative and in Postanesthesia care unit', 'description': 'measured before induction to general anesthesia, immediately after induction and every 15 min until the end of operation and immediately after awareness.at 15 min intervals starting upon arrival in the post anesthesia care unit'}, {'measure': 'PIPcmH20 ( Peak inspiratory pressure)', 'timeFrame': 'intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}, {'measure': 'duration of surgery (hr)', 'timeFrame': 'intrapostoperative', 'description': 'from the incision to the last skin suture'}, {'measure': 'The first flatus time (min)', 'timeFrame': 'up to 5 days', 'description': 'the first time that patient flatus postoperative'}, {'measure': 'duration of anesthesia time (min)', 'timeFrame': 'intraoperative', 'description': 'time from anesthesia induction to Extubation'}, {'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': 'until first postoperative day', 'description': 'incidence of PONV'}, {'measure': 'Hospitalization time ( days)', 'timeFrame': 'up to 2 weeks', 'description': 'FROM ADMISSION TO HOSPITAL TO DISCHARGE'}, {'measure': 'cumulative analgetid dose (mg)', 'timeFrame': 'until 2 PM the next day of the surgery', 'description': 'cumulative analgetid dose until 2 PM the next day of the surgery'}, {'measure': 'oxygen saturation (SpO2) %', 'timeFrame': 'intraoperative and in Postanesthesia care unit', 'description': 'measured before induction to general anesthesia, immediately after induction and every 15 min until the end of operation and immediately after awareness.at 15 min intervals starting upon arrival in the post anesthesia care unit'}, {'measure': 'tidal volume (ml)', 'timeFrame': 'Intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}, {'measure': 'Pplat cmH20 ( plateau pressure),', 'timeFrame': 'Intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}, {'measure': 'dynamic compliance ml/cmH20,', 'timeFrame': 'Intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}, {'measure': 'DP cmH20( Driving pressure)', 'timeFrame': 'Intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}, {'measure': 'Resistance cmH20/L/sec', 'timeFrame': 'Intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}, {'measure': 'PEEP cmH20', 'timeFrame': 'Intraoperative', 'description': 'Respiratory mechanical parameters were measured after intubation at suspine position, after insufflation of pneumoperitoneum , then the standard different positions of the patient ( Anti-Trendelenburg, supine, anti-trendelenburg and suspine position without premoperitoneum at the end of the procedure)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of depth of neuromuscular blockade on the surgical field, patient postoperative pain, intestinal motility, the incidence of postoperative nausea and vomiting and the effect of deep versus moderate neuromuscular blockade on postoperative atelectasis quantitatively using chest computed tomography.This is a prospective, randomized, controlled clinical-controlled study in patients ≥18 years old scheduled to undergo elective bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥18 years ASA II-III who are to undergo planned laparoscopic bariatric surgery\n\nExclusion Criteria:\n\n* ASA 4 patients\n* Maternal population\n* Patients who are not scheduled to receive general anesthesia, but some other type of anesthesia.\n* Contraindicated patients: administration of neuromuscular blockade, suppression of spontaneous respiration, and those with an indication for awake intubation or surgical airway.\n* Patients with neuromuscular diseases\n* Patients who refuse to participate in the study.'}, 'identificationModule': {'nctId': 'NCT06553066', 'briefTitle': 'Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Deep Versus Moderate Neuromuscular Blockade in Bariatric Surgery:', 'orgStudyIdInfo': {'id': 'Bariatric'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group DNMB ( Deep neuromascular blockage)', 'description': "Deep Neuromuscular Block group Intervention: maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2.\n\nQuality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)", 'interventionNames': ['Drug: Deep neuromascular blockage', 'Drug: Moderate neuromascular blockage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group MNMB ( Moderate neuromascular blockage)', 'description': "Moderate Neuromuscular Block group Intervention: maintenance of a moderate neuromuscular block with rocuronium, titrated to obtain a TOF count of 1-3.\n\nQuality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)", 'interventionNames': ['Drug: Deep neuromascular blockage', 'Drug: Moderate neuromascular blockage']}], 'interventions': [{'name': 'Deep neuromascular blockage', 'type': 'DRUG', 'otherNames': ['Rocuronium and Sugammadex'], 'description': "maintenance of a deep neuromuscular block with rocuronium, titrated to maintain a TOF count of 0, and a PTC between 1-2.\n\nQuality of surgical field conditions' assessed by a blind surgeon as a 5 points scale(Leiden scale : 1 indicates extremely poor conditions, 2 poor conditions, 3 acceptable conditions, 4, good conditions and 5 optimal conditions)", 'armGroupLabels': ['Group DNMB ( Deep neuromascular blockage)', 'Group MNMB ( Moderate neuromascular blockage)']}, {'name': 'Moderate neuromascular blockage', 'type': 'DRUG', 'otherNames': ['Rocuronium and Sugammadex'], 'description': 'maintenance of a moderate neuromuscular block with rocuronium, titrated to maintain a TOF count of 1-2', 'armGroupLabels': ['Group DNMB ( Deep neuromascular blockage)', 'Group MNMB ( Moderate neuromascular blockage)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nikolas Drakos, MD', 'role': 'CONTACT', 'email': 'nikolasdrakos@hotmail.com', 'phone': '+306998429336'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nikolas Drakos', 'investigatorAffiliation': 'University Hospital of Patras'}}}}