Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-03-05 @ 1:35 AM
Study NCT ID:
NCT05509192
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation', 'timeFrame': 'Between laryngoscope insertion to onset of ventilation (less than 7 minutes)'}], 'secondaryOutcomes': [{'measure': 'Number of participants for whom tracheal intubations were successful on the first attempt', 'timeFrame': 'after 5 minutes of successful ventilation'}, {'measure': 'Number of times tracheal intubations are attempted', 'timeFrame': 'after 5 minutes of successful ventilation'}, {'measure': 'Number of participants for whom tracheal intubations failed', 'timeFrame': 'after 3 failed intubation attempts (less than 7 minutes from start of intubation)'}, {'measure': 'Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)', 'timeFrame': 'from start of induction to 5 minutes of successful ventilation', 'description': 'data is reported categorically as follows 1(Full view of glottis),2a(Partial view of glottis), 2b(Only posterior extremity of glottis seen or only arytenoid cartilages), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)'}, {'measure': 'Heart Rate', 'timeFrame': 'from the start of induction drug administration to about 5 minutes after successful ventilation'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'from the start of induction drug administration to about 5 minutes after successful ventilation'}, {'measure': 'Systolic blood pressure', 'timeFrame': 'from the start of induction drug administration to about 5 minutes after successful ventilation'}, {'measure': 'End-tidal carbon dioxide (CO2) level', 'timeFrame': 'from the start of induction drug administration to about 5 minutes after successful ventilation'}, {'measure': 'Oxygen saturation (SpO2)', 'timeFrame': 'from the start of induction drug administration to about 5 minutes after successful ventilation'}, {'measure': 'Number of participants that had injury associated with intubation', 'timeFrame': 'within 24 hours after surgery', 'description': 'Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed'}, {'measure': 'Physical response during intubation, as assessed by the number of participants who moved', 'timeFrame': 'during surgery'}, {'measure': 'Physical response during intubation, as assessed by the number of participants who coughed', 'timeFrame': 'during surgery'}, {'measure': 'Number of participants who had Awareness of muscle paralysis before loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction', 'timeFrame': 'within one hour after surgery'}, {'measure': 'Number of participants who had presence of Sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction', 'timeFrame': 'within one hour after surgery', 'description': 'This is scored from 0(no pain) to 10(worst pain)'}, {'measure': 'Number of participants who had nausea and vomiting as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction', 'timeFrame': 'within one hour after surgery'}, {'measure': 'Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction', 'timeFrame': 'within one hour after surgery', 'description': 'This is scored from 0(not satisfied) to 10(extremely satisfied)'}, {'measure': 'Number of participants who had recollection of pain on induction', 'timeFrame': 'within one hour after surgery'}, {'measure': 'Provider determination of intubating conditions, based on whether intubation was classified as "Not difficult" or "Difficult"', 'timeFrame': 'at time of surgery'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>30 kg/M2 or Mallampati class III or IV\n* Requiring general anesthesia and endotracheal intubation\n\nExclusion Criteria:\n\n* Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease (COPD) and asthma\n* American Society of Anesthesiologists (ASA) physical status classification \\> III\n* Emergency surgery\n* Induction requiring cricoid pressure\n* Patients requiring awake intubation\n* Pregnant women\n* Patients who require an induction dose of propofol less than 1 mg/kg\n* Untreated ischemic heart disease\n* Contraindication to mask ventilation\n* Allergy to propofol, rocuronium, or Sugammadex\n* Induction requiring succinylcholine'}, 'identificationModule': {'nctId': 'NCT05509192', 'briefTitle': 'Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-22-0495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MTPI group', 'interventionNames': ['Drug: MTPI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic Induction group', 'interventionNames': ['Drug: Classic Induction']}], 'interventions': [{'name': 'MTPI', 'type': 'DRUG', 'description': "Patients from both study groups will receive premedication in the usual fashion, typically 0-2 mg of IV midazolam at the discretion of the care team. Patients in both study groups will receive 1 mg/kg of lidocaine intravenously, followed by an opioid such as fentanyl (1-2 mcg/kg), prior to administration of induction drugs. Patients assigned to MTPI will then be given rocuronium (0.6mg/kg), followed by propofol intravenously as a single bolus within 10 seconds. A typical propofol bolus for induction ranges from 1-2mg/kg, depending on the patient's age, medical history, and co-morbidities. Propofol dosing will be at the discretion of the care team. Patients will count down from one hundred. Once apnea occurs, as indicated by a lack of respiratory effort, the eyes will be taped, and intubation with C-MAC (Karl Storz 8403ZX, Tuttlingen, Germany) is initiated.", 'armGroupLabels': ['MTPI group']}, {'name': 'Classic Induction', 'type': 'DRUG', 'description': 'Patients assigned to CI will be induced as per routine care using lidocaine 1 mg/kg, an opioid such a fentanyl (1-2 mcg/kg), propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg, and the intubation will be performed with a C-MAC. Patients will also count down from one hundred. The medications used for induction of anesthesia in both arms of the study are those used for routine anesthesia care. In both study arms, dosing of medications for induction of anesthesia is standardized (lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg). The only difference between the two arms will be the timing of the medication administration, and the order in which medications are administered. The documentation of induction and intubation will be the same as that of the MTPI group. Vital signs and other parameters will continuously be recorded in the intraoperative record. Emergence and extubation are not protocolized.', 'armGroupLabels': ['Classic Induction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Lauren M Nakazawa, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lauren Nakazawa', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}