Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT03276533
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2017-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2017-08-23', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-6', 'timeFrame': 'postoperative 24 hours', 'description': 'Interleukin-6 level in serum was measured at the before administration of drugs (T1), Interleukin-6 level in serum was measured at the end of the operation (T2); Interleukin-6 level in serum was measured at the postoperative 2 hour (T3); Interleukin-6 level in serum was measured at the postoperative 24 hour (T4)'}, {'measure': 'Tumor necrosis factor-α', 'timeFrame': 'postoperative 24 hours', 'description': 'Tumor necrosis factor-α level in serum was measured at the before administration of drugs (T1); Tumor necrosis factor-α level in serum was measured at the end of the operation (T2); Tumor necrosis factor-α level in serum was measured at the postoperative 2 hour (T3); Tumor necrosis factor-α level in serum was measured at the postoperative 24 hour (T4)'}, {'measure': 'Interleukin-1', 'timeFrame': 'postoperative 24 hours', 'description': 'Interleukin-1 level in serum was measured at the before administration of drugs (T1); Interleukin-1 level in serum was measured at the end of the operation (T2); Interleukin-1 level in serum was measured at the postoperative 2 hour (T3); Interleukin-1 level in serum was measured at the postoperative 24 hour (T4)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine; lidocaine; cytokine'], 'conditions': ['Anesthesia; Reaction']}, 'referencesModule': {'references': [{'pmid': '33407156', 'type': 'DERIVED', 'citation': 'Xu S, Hu S, Ju X, Li Y, Li Q, Wang S. Effects of intravenous lidocaine, dexmedetomidine, and their combination on IL-1, IL-6 and TNF-alpha in patients undergoing laparoscopic hysterectomy: a prospective, randomized controlled trial. BMC Anesthesiol. 2021 Jan 6;21(1):3. doi: 10.1186/s12871-020-01219-z.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The present study was to evaluate the effects of dexmedetomidine alone, lidocaine alone and their combined infusion on postoperative inflammation cytokines after Laparoscopic hysterectomy.\n\nMethods: Investigators enrolled 160 women with American Society of Anesthesiologists (ASA) physical status I and II, aged 40-65 years, and scheduled for elective laparoscopic hysterectomy with general anesthesia from October 2017 to August 2018. The participants were randomly assigned into four groups(n=40 each group): group CON received normal saline infusion, group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion), group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and group LIDO+DEX received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusions (0.5 µg/kg loading, 0.4 µg/kg/h infusion). The four groups received an IV bolus infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of normal saline, lidocaine, dexmedetomidine and lidocaine combined with dexmedetomidine until abdominal wound closure, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), the end of surgery (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I and II\n* weighted 50 kg-65 kg\n* aged 40-65 yr\n* elective laparoscopic hysterectomy with general anesthesia\n\nExclusion Criteria:\n\n* a history of allergy to local anesthetics\n* severe respiratory, renal or hepatic disease\n* preoperative opioids medication\n* psychiatric medical history\n* Patients with severe hypotension \\[mean arterial pressure (MAP\\<60 mmHg)\\] or bradycardia \\[heart rate (HR) \\<40 beats per minute (bpm)\\], arrhythmia, or urticaria due to lidocaine and dexmedetomidine infusion during the surgery'}, 'identificationModule': {'nctId': 'NCT03276533', 'briefTitle': 'Dexmedetomidine Combined With Lidocaine Infusion Affect Inflammation Cytokines', 'organization': {'class': 'OTHER', 'fullName': 'Anqing Municipal Hospital'}, 'officialTitle': 'Effects of Intravenous Dexmedetomidine, Lidocaine and Their Combination on Postoperative Inflammation Cytokines After Laparoscopic Hysterectomy With General Anesthesia', 'orgStudyIdInfo': {'id': 'xuzhang2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous saline, dexmedetomidine and lidocaine', 'interventionNames': ['Drug: Saline', 'Drug: Lidocaine', 'Drug: Dexmedetomidine', 'Drug: Lidocaine plus Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous saline, dexmedetomidine, lidocaine and combination', 'interventionNames': ['Drug: Saline', 'Drug: Lidocaine', 'Drug: Dexmedetomidine', 'Drug: Lidocaine plus Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous saline,dexmedetomidine plus lidocaine', 'interventionNames': ['Drug: Saline', 'Drug: Lidocaine', 'Drug: Dexmedetomidine', 'Drug: Lidocaine plus Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous saline, dexmedetomidine combined with lidocaine', 'interventionNames': ['Drug: Saline', 'Drug: Lidocaine', 'Drug: Dexmedetomidine', 'Drug: Lidocaine plus Dexmedetomidine']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'description': 'Participants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)', 'armGroupLabels': ['Intravenous saline, dexmedetomidine and lidocaine', 'Intravenous saline, dexmedetomidine combined with lidocaine', 'Intravenous saline, dexmedetomidine, lidocaine and combination', 'Intravenous saline,dexmedetomidine plus lidocaine']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Participants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)', 'armGroupLabels': ['Intravenous saline, dexmedetomidine and lidocaine', 'Intravenous saline, dexmedetomidine combined with lidocaine', 'Intravenous saline, dexmedetomidine, lidocaine and combination', 'Intravenous saline,dexmedetomidine plus lidocaine']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Participants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)', 'armGroupLabels': ['Intravenous saline, dexmedetomidine and lidocaine', 'Intravenous saline, dexmedetomidine combined with lidocaine', 'Intravenous saline, dexmedetomidine, lidocaine and combination', 'Intravenous saline,dexmedetomidine plus lidocaine']}, {'name': 'Lidocaine plus Dexmedetomidine', 'type': 'DRUG', 'description': 'Participants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)', 'armGroupLabels': ['Intravenous saline, dexmedetomidine and lidocaine', 'Intravenous saline, dexmedetomidine combined with lidocaine', 'Intravenous saline, dexmedetomidine, lidocaine and combination', 'Intravenous saline,dexmedetomidine plus lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '246000', 'city': 'Anqing', 'state': 'Anhui', 'country': 'China', 'facility': 'Department of Anqing Hospital Anesthesiology', 'geoPoint': {'lat': 30.51365, 'lon': 117.04723}}], 'overallOfficials': [{'name': 'Wang shenbing', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anqing Hospital Anesthesiology'}, {'name': 'Xiao jingbo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anqing Hospital Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anqing Municipal Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator,Department of Anesthesiology', 'investigatorFullName': 'Xu Siqi', 'investigatorAffiliation': 'Anqing Municipal Hospital'}}}}