Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-26 @ 1:43 PM
Study NCT ID:
NCT04706767
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of recovery scores(QoR-40)', 'timeFrame': '1 day after operation', 'description': 'Our primary outcome was Quality of recovery scores(QoR-40) 1 day after operation'}], 'secondaryOutcomes': [{'measure': 'Intraoperative remifentanil total dose', 'timeFrame': 'Intraoperative', 'description': 'Secondary Outcome Measure was remifentanil total dose during the perioperative period'}, {'measure': 'Recovery time', 'timeFrame': 'Immediately after the surgery', 'description': 'Secondary Outcome Measure was recovery time'}, {'measure': 'Extubation time', 'timeFrame': 'Immediately after the surgery', 'description': 'Secondary Outcome Measure was extubation time'}, {'measure': 'Pain visual analogue scale scores', 'timeFrame': 'The first 24 hours after operation', 'description': 'Secondary Outcome Measure was pain visual analogue scale scores'}, {'measure': 'PONV scores', 'timeFrame': 'The first 24 hours after operation', 'description': 'Secondary Outcome Measure was PONV scores'}, {'measure': 'The consumption of sufentanil', 'timeFrame': 'The first 24 hours after operation', 'description': 'Secondary Outcome Measure was consumption of sufentanil'}, {'measure': 'The length of post-anesthesiacare unit stay', 'timeFrame': 'Immediately after the surgery', 'description': 'Secondary Outcome Measure was the length of post-anesthesiacare unit stay'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lidocaine', 'Dexmedetomidine', 'Quality of recovery'], 'conditions': ['Lidocaine', 'Dexmedetomidine', 'Quality of Recovery(QoR-40), Preoperative and Postoperative']}, 'descriptionModule': {'briefSummary': 'BACKGROUND: Some studies have revealed that intravenous (IV) lidocaine or dexmedetomidine might improve the quality of recovery undergoing laparoscopic surgery. The investigators investigated whether co-administration lidocaine and dexmedetomidine could better improve the the quality of recovery after laparoscopic total hysterectomy.\n\nMETHODS: One hundred and forty-four women with elective laparoscopic total hysterectomy were randomly divided into four groups: Patients in group L received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close the pneumoperitoneum. Patients in group D received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close the pneumoperitoneum. Patients in group LD received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close the pneumoperitoneum, respectively. Patients in group C received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close the pneumoperitoneum. Primary outcome was the quality of recovery (QoR-40) at 1 day prior to sugery, 1 day after sugery, and 2 days after sugery. The secondary outcomes included perioperative remifentanil consumption, postoperative VAS scores, the incidence of postoperative nausea and vomiting, postoperative rescue analgesics and anti-emetics, recovery time, extubation time, and Ramsay sedation scale at 5 min, 10min, 30 min, 60 min after extubation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ\n* Scheduled for elective laparoscopic total hysterectomy\n\nExclusion Criteria:\n\n* History of allergy to local anesthetics\n* BMI\\>30\n* Severe respiratory disease\n* Renal or hepatic insufficiency\n* History of preoperative opioids medication and psychiatric\n* preoperative bradycardia\n* preoperative atrioventricular block'}, 'identificationModule': {'nctId': 'NCT04706767', 'briefTitle': 'Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Anqing Municipal Hospital'}, 'officialTitle': 'Effects of Lidocaine, Dexmedetomidine, and Their Combination on Quality of Recovery Undergoing Laparoscopic Total Hysterectomy', 'orgStudyIdInfo': {'id': 'xuzhang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery', 'interventionNames': ['Drug: Co-administration Lidocaine and Dexmedetomidine', 'Drug: Dexmedetomidine infusion', 'Drug: Lidocaine infusion', 'Drug: Saline infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Effect of Dexmedetomidine infusion on Quality of Recovery', 'interventionNames': ['Drug: Co-administration Lidocaine and Dexmedetomidine', 'Drug: Dexmedetomidine infusion', 'Drug: Lidocaine infusion', 'Drug: Saline infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Effect of Lidocaine infusion on Quality of Recovery', 'interventionNames': ['Drug: Co-administration Lidocaine and Dexmedetomidine', 'Drug: Dexmedetomidine infusion', 'Drug: Lidocaine infusion', 'Drug: Saline infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Effect of saline infusion on Quality of Recovery', 'interventionNames': ['Drug: Co-administration Lidocaine and Dexmedetomidine', 'Drug: Dexmedetomidine infusion', 'Drug: Lidocaine infusion', 'Drug: Saline infusion']}], 'interventions': [{'name': 'Co-administration Lidocaine and Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.', 'armGroupLabels': ['Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery', 'Effect of Dexmedetomidine infusion on Quality of Recovery', 'Effect of Lidocaine infusion on Quality of Recovery', 'Effect of saline infusion on Quality of Recovery']}, {'name': 'Dexmedetomidine infusion', 'type': 'DRUG', 'description': 'Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.', 'armGroupLabels': ['Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery', 'Effect of Dexmedetomidine infusion on Quality of Recovery', 'Effect of Lidocaine infusion on Quality of Recovery', 'Effect of saline infusion on Quality of Recovery']}, {'name': 'Lidocaine infusion', 'type': 'DRUG', 'description': 'Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.', 'armGroupLabels': ['Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery', 'Effect of Dexmedetomidine infusion on Quality of Recovery', 'Effect of Lidocaine infusion on Quality of Recovery', 'Effect of saline infusion on Quality of Recovery']}, {'name': 'Saline infusion', 'type': 'DRUG', 'description': 'Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.', 'armGroupLabels': ['Effect of Co-administration Lidocaine and Dexmedetomidine on Quality of Recovery', 'Effect of Dexmedetomidine infusion on Quality of Recovery', 'Effect of Lidocaine infusion on Quality of Recovery', 'Effect of saline infusion on Quality of Recovery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '246000', 'city': 'Anqing', 'state': 'Anhui', 'country': 'China', 'facility': 'Department of Anqing Hospital Anesthesiology', 'geoPoint': {'lat': 30.51365, 'lon': 117.04723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anqing Municipal Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}