Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:08 AM
Study NCT ID:
NCT07333859
Status:
RECRUITING
Last Update Posted:
2026-03-06
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-03', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Endoscopist Satisfaction Score', 'timeFrame': 'From induction until the end of the procedure', 'description': 'An 11-point Numerical Rating Scale (NRS) used by the endoscopist to evaluate the ease of the procedure regarding patient movements and visceral reflexes (such as gagging, coughing, or hiccups).\n\nThe scale ranges from 0 to 10, where:\n\n0 = Poor conditions (Severe interference, procedure nearly impossible to perform); 10 = Excellent conditions (No interference/perfect conditions).'}, {'measure': 'Incidence of Sedation-Related Adverse Events', 'timeFrame': 'From induction until the end of the procedure', 'description': 'The frequency of adverse events including hypotension (MAP drop \\>20% from baseline), bradycardia (Heart rate \\<50 bpm), and hypoxemia (SpO2 \\<90%).'}, {'measure': 'Incidence of Significant Procedural Interference', 'timeFrame': 'From induction until the end of the procedure', 'description': 'The number of participants who experienced one or more visceral reflexes (gagging, coughing, or hiccups) or body movements that required a temporary halt or adjustment of the endoscopic intervention.'}, {'measure': 'Recovery Time to Discharge Readiness', 'timeFrame': 'From the completion of the ERCP procedure until discharge criteria are met (approximately 30-120 minutes).', 'description': 'The time interval (in minutes) from the end of the ERCP procedure until the patient achieves a Modified Aldrete Score of ≥9, indicating readiness for discharge from the post-anesthesia care unit (PACU).'}], 'primaryOutcomes': [{'measure': 'Rescue Spasmolytic Requirement Rate', 'timeFrame': 'Intraoperative (During the ERCP procedure, approx. 30 minutes)', 'description': 'The proportion of patients requiring rescue medication (Hyoscine-N-butylbromide or Glucagon) due to severe duodenal spasm preventing cannulation.'}], 'secondaryOutcomes': [{'measure': 'Total Propofol Consumption', 'timeFrame': 'From induction until the end of the procedure', 'description': 'The total amount of intravenous propofol (measured in milligrams) required to maintain the target sedation depth (RSS 3-4 and BIS 60-80) from the start of induction until the completion of the ERCP procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lidocaine', 'Peristalsis', 'Intravenous Anesthesia', 'deep sedation', 'Duodenoscopy'], 'conditions': ['Duodenal Spasm', 'ERCP', 'Sedation']}, 'referencesModule': {'references': [{'pmid': '41321955', 'type': 'BACKGROUND', 'citation': 'Suzuki M, Sekino Y, Hosono K, Kurita Y, Uechi H, Kuzuu K, Uchiyama S, Kawana K, Nagase H, Kubota K, Yoneda M, Nakajima A. Inhibitory Effect of Lidocaine on Duodenal Peristalsis During Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Trial (With Video). DEN Open. 2025 Nov 27;6(1):e70252. doi: 10.1002/deo2.70252. eCollection 2026 Apr.'}, {'pmid': '26866299', 'type': 'BACKGROUND', 'citation': 'Abrahams M, Derby R, Horn JL. Update on Ultrasound for Truncal Blocks: A Review of the Evidence. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):275-88. doi: 10.1097/AAP.0000000000000372.'}, {'pmid': '26631626', 'type': 'BACKGROUND', 'citation': 'Busch R, Murti K, Liu J, Patra AK, Muhammad K, Knobeloch KP, Lichtinger M, Bonifer C, Wortge S, Waisman A, Reifenberg K, Ellenrieder V, Serfling E, Avots A. NFATc1 releases BCL6-dependent repression of CCR2 agonist expression in peritoneal macrophages from Saccharomyces cerevisiae infected mice. Eur J Immunol. 2016 Mar;46(3):634-46. doi: 10.1002/eji.201545925. Epub 2016 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy of intravenous lidocaine infusion on duodenal peristalsis during Endoscopic Retrograde Cholangiopancreatography (ERCP). The study compares lidocaine against a placebo to determine if lidocaine can reduce the need for rescue spasmolytics (hyoscine-N-butylbromide or glucagon), decrease propofol consumption, and improve hemodynamic stability.', 'detailedDescription': 'Duodenal peristalsis can hinder successful cannulation during ERCP. Traditionally, antispasmodics like hyoscine-N-butylbromide are used but have side effects. This randomized, double-blind, placebo-controlled trial includes 120 patients (ASA I-III) undergoing elective ERCP. "All patients will undergo a standardized sedation protocol managed by an anesthesiologist. Sedation induction will be performed with a loading dose of propofol (0.5-1 mg/kg). Maintenance of sedation will be achieved through a continuous infusion of propofol (40-60 µg/kg/min), supplemented by intermittent bolus doses of 20-30 mg as clinically required. The sedation level will be dynamically titrated by the physician to maintain a target Ramsay Sedation Scale (RSS) score of 3-4 and Bispectral Index (BIS) values between 60 and 80. This approach ensures patient comfort and procedural stability while minimizing respiratory depression\n\nPatients will be randomized 1:1 into two groups:\n\nGroup L (Lidocaine): IV bolus 1.0 mg/kg before induction + 2.0 mg/kg/h continuous infusion during the procedure.\n\nGroup C (Control): Equal volume of 0.9% Saline. Primary outcome is the "Rescue Spasmolytic Requirement" based on endoscopist\'s evaluation. Secondary outcomes include duodenal peristalsis score (Suzuki Scale) assessed via video review by a blinded endoscopist, total propofol consumption, and recovery times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective ERCP.\n\nASA Physical Status I, II, or III.\n\nAge between 18 and 85 years.\n\nProvided written informed consent.\n\nExclusion Criteria:\n\n* Allergy to amide-type local anesthetics.\n\nSevere hepatic or renal failure.\n\nHistory of AV block or severe cardiac arrhythmia.\n\nPregnancy or lactation.\n\nChronic opioid use.\n\nPatient refusal.'}, 'identificationModule': {'nctId': 'NCT07333859', 'acronym': 'LIDO ERCP', 'briefTitle': 'Effect of IV Lidocaine on Duodenal Peristalsis and Sedation in ERCP', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Effect of Intravenous Lidocaine Infusion on Duodenal Peristalsis, Sedation Quality and Rescue Spasmolytic Requirement in ERCP Procedures: A Randomized, Double-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'ERCP-LIDO-2026-01'}, 'secondaryIdInfos': [{'id': 'MEHMET SAHAP', 'type': 'OTHER', 'domain': 'ANKARA BILKENT CITY HOSPİTAL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine Group', 'description': '1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure.', 'interventionNames': ['Drug: Lidocaine Hydrochloride 2%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.', 'interventionNames': ['Other: 0.9 % Normal Saline']}], 'interventions': [{'name': 'Lidocaine Hydrochloride 2%', 'type': 'DRUG', 'description': '1.0 mg/kg IV bolus followed by 2.0 mg/kg/h IV infusion during the procedure. Propofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required.', 'armGroupLabels': ['Lidocaine Group']}, {'name': '0.9 % Normal Saline', 'type': 'OTHER', 'description': 'IV bolus and infusion of 0.9% NaCl matched in volume and rate to the study drug.\n\nPropofol Induction: 0.5-1 mg/kg loading dose, Maintenance: Continuous infusion of 40-60 µg/kg/min, supplemented by intermittent 20-30 mg boluses as clinically required..', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06610', 'city': 'Ankara', 'state': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet Sahap Mehmet, MD', 'role': 'CONTACT', 'email': 'drsahap@gmail.com', 'phone': '0(312) 552 66 00'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Mehmet Şahap, MD', 'role': 'CONTACT', 'email': 'drsahap@gmail.com', 'phone': '+95336826254'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '"Individual participant data will not be shared due to privacy concerns and the lack of a dedicated data management infrastructure to ensure secure anonymization.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asist Prof Dr', 'investigatorFullName': 'Mehmet sahap', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}