Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-29 @ 9:47 AM
Study NCT ID:
NCT06045559
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Anesthetics on High-Dose Rocuronium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'targetDuration': '3 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of neuromuscular block with rocuronium.', 'timeFrame': '15 seconds for TOF rates, 8 minutes for PTC values', 'description': 'TOF rates will be measured every 15 seconds and PTC values will be measured every 8 minutes. Additionally, the times of TOF 0 and PTC 0 responses and TOF1 and PTC 1 responses will be recorded.'}], 'secondaryOutcomes': [{'measure': 'intra-abdominal pressure', 'timeFrame': '5 minutes', 'description': 'Effect of deep neuromuscular block on intra-abdominal pressure'}, {'measure': 'surgical conditions', 'timeFrame': "It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.", 'description': 'Effect of deep neuromuscular block on surgical conditions'}, {'measure': 'postoperative pain', 'timeFrame': '2nd, 24th and 72nd hours after surgery', 'description': 'Effect of deep neuromuscular block on postoperative pain'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': 'postoperative 4th, 12th and 24th hours', 'description': 'The effect of deep neuromuscular blockade on postoperative nausea and vomiting will be evaluated.'}, {'measure': 'Length of extubation process', 'timeFrame': '15sc', 'description': 'Time from discontinuation of maintenance anesthesia to extubation.'}, {'measure': 'Lenght of recovery process', 'timeFrame': '1 mınute', 'description': 'Time from extubation to modified Aldrete score of 9.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inhalational anesthetics', 'Neuromuscular Blockade', 'rocuronium'], 'conditions': ['Neuromuscular Blockade', 'Anesthetic Agents']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups. Train of four (TOF) and bispectral index (BIS) monitoring were used during surgery in all groups.Patients were followed until TOF and post tetanic count (PTC) values reached 1 and the time was recorded.The effect of three anesthetic drugs used on the duration of the muscle relaxant drug was investigated.', 'detailedDescription': 'In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intraabdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative nausea and vomiting (PONV) and pain can be reduced.\n\nThe results we obtained in our previous study showed that deep neuromuscular block achieved with a high dose of 1.2 mg/kg rocuronium allowed the operation to be performed with lower intra-abdominal pressure values, shortened the operation time, reduced PONV and pain in laparoscopic cholecystectomy cases. The most important factor affecting the depth of neuromuscular block is the dose of the neuromuscular agent. However, anesthetic agents can also affect the depth of neuromuscular blockade. The effects of muscle relaxants are enhanced when administered together with inhalation anesthetics.Propofol and sevoflurane are widely used in the maintenance of anesthesia. Unlike propofol, sevoflurane enhances the effects of some neuromuscular blocking drugs, including rocuronium.\n\nOur primary aim in this study is to evaluate the effects of sevoflurane, desflurane, or propofol, which are commonly used in anesthesia maintenance, on the duration of neuromuscular block caused by 1.2 mg/kg rocuronium, which is the dose we routinely use in anesthesia induction, in laparoscopic cholecystectomy cases. Secondary aims are to investigate its effects on intraabdominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18 and 65 who applied to our hospital for laparoscopic cholecystectomy surgery from October 2023 to June 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology (ASA) Ⅰ-Ⅲ patients\n* between the ages of 18-65\n\nExclusion Criteria:\n\n* Being under 18 of age or over 65\n* disapproval of the informed consent\n* rocuronium allergy\n* sugammadex allergy\n* pregnancy\n* lactation\n* hepatic or renal dysfunction\n* obesity (BMI≥35kg/m2)\n* Previous abdominal surgery\n* long-term use of NSAIs\n* neuromuscular disorders'}, 'identificationModule': {'nctId': 'NCT06045559', 'briefTitle': 'Effects of Anesthetics on High-Dose Rocuronium', 'organization': {'class': 'OTHER', 'fullName': 'Mustafa Kemal University'}, 'officialTitle': 'Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations', 'orgStudyIdInfo': {'id': '2022/38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'S(Sevoflurane)', 'description': 'Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with sevoflurane, with a BIS value between 40-50 and a minimal alveolar concentration (MAC) value between 1-1.5.'}, {'label': 'D(Desflurane)', 'description': 'Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with desflurane, with a BIS value between 40-50 and a MAC value between 1-1.5.'}, {'label': 'P(Propofol)', 'description': 'Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Propofol was administered intravenously at a rate of 6-12 mg/kg/min to maintain anesthesia, keeping the BIS value between 40-50.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31100', 'city': 'Antakya', 'state': 'Hatay', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Selim Turhanoglu, MD', 'role': 'CONTACT', 'email': 'adat63@gmail.com', 'phone': '+905325062988'}], 'facility': 'Hatay Mustafa Kemal University', 'geoPoint': {'lat': 36.20655, 'lon': 36.15722}}], 'centralContacts': [{'name': 'Selim Turhanoglu, MD', 'role': 'CONTACT', 'email': 'adat63@gmail.com', 'phone': '+905325062988'}, {'name': 'Menekşe Okşar, MD', 'role': 'CONTACT', 'email': 'menekseoksar@gmail.com', 'phone': '+905337108301'}], 'overallOfficials': [{'name': 'Selim Turhanoglu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mustafa Kemal University'}, {'name': 'Serhat Hakkoymaz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mustafa Kemal University'}, {'name': 'Menekşe Okşar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mustafa Kemal University'}, {'name': 'Muhyittin Temiz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mustafa Kemal University'}, {'name': 'Emre Dirican', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mustafa Kemal University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mustafa Kemal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.', 'investigatorFullName': 'Selim Turhanoglu', 'investigatorAffiliation': 'Mustafa Kemal University'}}}}