Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 9:56 AM
Study NCT ID:
NCT05750056
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2023-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D017409', 'term': 'Sufentanil'}], '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'}, {'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': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-01-28', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Emergency time', 'timeFrame': 'Immediately after the colonoscopy completely withdrawn', 'description': 'Emergency time is defined as the interval from the end of colonoscopy to the MOAA/S score equal to five.'}, {'measure': 'Patient willingness to recommend screening', 'timeFrame': 'Day 1 postoperatively', 'description': 'Patients will be asked whether they would recommend bronchoscopy screening to a friend or a relative (Yes/No/Unsure).'}, {'measure': 'Patient willingness to repeat the procedure', 'timeFrame': 'Day 1 postoperatively', 'description': 'Patients will be asked whether they would repeat the identical procedural process (Yes/No/Unsure)'}], 'primaryOutcomes': [{'measure': 'Incidence of postoperative cognitive recovery', 'timeFrame': 'Day 3 postoperatively', 'description': 'Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperative cognitive recovery', 'timeFrame': '30 minutes after endoscope removal', 'description': 'Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.'}, {'measure': 'Incidence of postoperative cognitive recovery', 'timeFrame': 'Day 1 postoperatively', 'description': 'Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.'}, {'measure': 'Incidence of postoperative cognitive recovery', 'timeFrame': 'Day 7 postoperatively', 'description': 'Postoperative cognitive recovery will be measured using the Postoperative Quality of Recovery Scale (PostopQRS). The PostopQRS is a multidimensional survey-based tool, which includes a domain designed to measure recovery in the cognitive domain of the PostopQRS over time during the postoperative period. The instrument is administered preoperatively to provide individual baseline measurements for each patient. Tests produce performance scores. Higher scores mean a better outcome. The recovery outcome is defined as returning to at least baseline values.'}, {'measure': 'Incidence of overall recovery', 'timeFrame': '30 minutes after endoscope removal', 'description': 'The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.'}, {'measure': 'Incidence of overall recovery', 'timeFrame': 'Day 1 postoperatively', 'description': 'The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.'}, {'measure': 'Incidence of overall recovery', 'timeFrame': 'Day 3 postoperatively', 'description': 'The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.'}, {'measure': 'Incidence of overall recovery', 'timeFrame': 'Day 7 postoperatively', 'description': 'The Postoperative Quality of Recovery Scale (PostopQRS) is a multidimensional survey-based tool, which contains physiological, emotive, nociceptive, activities of daily living, and cognitive recovery over time. Nociceptive, emotive, and activities of daily living that can be scored in a categorical fashion. In the cognitive domain, tasks receive a performance score. In the physiologic domain, values are transformed and categorized as acceptable, somewhat or far outside of the desirable boundaries, based on normative population data. Higher scores mean a better outcome, except for nociceptive domain. Overall recovery is postoperative values equaling or exceeding individual baseline values in each of the domains of the PostopQRS. The incidence of recovery is expressed as a percentage of participants recovered/group total at each time point.'}, {'measure': 'Propofol consumption', 'timeFrame': 'During the colonoscopy procedure', 'description': 'Propofol consumption will be recorded during the colonoscopy procedure.'}, {'measure': 'Endoscopitst satisfacrion', 'timeFrame': 'At completion of colonoscopy procedure', 'description': 'Endoscopitst satisfacrion will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).'}, {'measure': 'Patient satisfaction', 'timeFrame': 'On 1 day postoperatively', 'description': 'Patient satisfaction will be evaluated using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 24 hours postoperatively', 'description': 'Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic submucosal dissection', 'lidocaine', 'cognitive recovery', 'quality of recovery'], 'conditions': ['Postoperative Recovery']}, 'referencesModule': {'references': [{'pmid': '41312048', 'type': 'DERIVED', 'citation': 'Liang Y, Qian B, Zhuo Y, Zhang J, Gao W, Li H, Zhang X, Lin W. Intravenous Lidocaine and Cognitive Recovery After Endoscopic Submucosal Dissection: A Randomized Controlled Trial. Drug Des Devel Ther. 2025 Nov 22;19:10343-10355. doi: 10.2147/DDDT.S557688. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': "Endoscopic submucosal dissection (ESD) is a common procedure that requires a long procedural time. Procedure Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures. We conducted a prospective study to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD.", 'detailedDescription': "Colorectal cancer occurred in more than 1.9 million new cases and 935,000 deaths in 2020 and ranked third in incidence and second in mortality globally. Endoscopic submucosal dissection (ESD) is the current standard for treating large colorectal polyps and has been shown to reduce colorectal cancer-related mortality. Sedation is commonly provided to alleviate patients' discomfort and facilitate the implementation of procedures.\n\nLidocaine is an amide local anesthetic with analgesic, anti-hyperalgesic, and anti-inflammatory properties. Its safety in appropriate amounts has been established. The current evidence gap is whether the use of systematic lidocaine affects the quality of recovery after ESD. Thus, the aim of this study is to determine the effect of intravenous infusion of lidocaine in the cognitive domain of the postoperative quality of recovery scale on day 3 after ESD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) classification I-III;\n2. Scheduled for endoscopic colorectal mucosal dissection.\n\nExclusion Criteria:\n\n1. Patient refuses to participate;\n2. BMI greater than 30;\n3. Allergic or contraindication to study drugs;\n4. History of chronic pain and long-term use of analgesic medication;\n5. Severe arrhythmia;\n6. Hepatic and renal dysfunction;\n7. Any other conditions precluded study inclusion, such as cognitive impairment, pregnancy, or inability to communicate in Mandarin Chinese.'}, 'identificationModule': {'nctId': 'NCT05750056', 'briefTitle': 'Dose Systemic Lidocaine Improve the Quality of Recovery After Colorectal Endoscopic Submucosal Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Effect of Intraoperative Intravenous Lidocaine on the Quality of Recovery Following Colorectal Endoscopic Submucosal Dissection', 'orgStudyIdInfo': {'id': 'K2020-05-029-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the surgery.', 'interventionNames': ['Drug: lidocaine', 'Drug: Propofol', 'Drug: Sufentanil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Patients received a perioperative 0.9% saline infusion at the same rate as the lidocaine infusion.', 'interventionNames': ['Drug: 0.9% saline', 'Drug: Propofol', 'Drug: Sufentanil']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'otherNames': ['Lidocaine IV'], 'description': 'Patients received an intravenous bolus injection of lidocaine 1.5 mg/kg over 10 min before induction of anesthesia, followed by a continuous infusion of 2 mg/kg/h until the end of the procedure.', 'armGroupLabels': ['Lidocaine group']}, {'name': '0.9% saline', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride'], 'description': 'Patients received a perioperative saline infusion at the same rate and volume as the lidocaine infusion.', 'armGroupLabels': ['Placebo group']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol injection'], 'description': 'An i.v. bolus injection of propofol 1 mg/kg was given to all patients. Propofol was then titrated if necessary to produce unconsciousness during the introduction of the endoscope. Afterward, the anesthesiologist determined the dose of propofol and titrated to effect.', 'armGroupLabels': ['Lidocaine group', 'Placebo group']}, {'name': 'Sufentanil', 'type': 'DRUG', 'otherNames': ['Sufentanil injection'], 'description': 'Sufentail 0.1 ug/kg was administered for sedation induction.', 'armGroupLabels': ['Lidocaine group', 'Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian provincial hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Xiaochun Zheng, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fujian Provincial Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'We would like to share our IPD beginning 3 months following the publication of the main results.', 'ipdSharing': 'YES', 'description': 'After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.', 'accessCriteria': 'All of the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yao Yusheng', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}