Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-01-24 @ 11:32 PM
Study NCT ID:
NCT02323958
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-23', 'lastUpdatePostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to awake', 'timeFrame': 'from end of inhaling sevoflurane to departing from postanesthesia care unit(PACU),an anticipated average of 1 hour', 'description': 'time to open eyes to verbal command'}], 'secondaryOutcomes': [{'measure': 'Richmond Score', 'timeFrame': 'from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour', 'description': 'status of the patients during emergence'}, {'measure': 'Time to extubation', 'timeFrame': 'from end of inhaling sevoflurane to departing from PACU,an anticipated average of 1 hour'}, {'measure': 'QoR-15', 'timeFrame': 'from end of inhaling sevoflurane to 24h after surgery,an anticipated average of 24 hour', 'description': 'Score of quality of recovery using a 15 items questionaire'}, {'measure': 'residual sedation', 'timeFrame': 'from arriving at PACU to departing from PACU,an anticipated average of 30min'}, {'measure': 'PONV', 'timeFrame': 'from arriving at PACU to departing from PACU,an anticipated average of 30min', 'description': 'postoperative nausea and vomiting in the PACU'}, {'measure': 'VAS score', 'timeFrame': 'from arriving at PACU to departing from PACU,an anticipated average of 30min', 'description': 'visual analogue score of pain in the PACU, scored 0-10'}, {'measure': 'serum Aquaporin 4', 'timeFrame': 'from before anesthesia to after surgery, an anticipated average of 4 hours', 'description': 'level of serum Aquaporin 4 before anesthesia and at the end of the surgery'}, {'measure': 'serum MMP9', 'timeFrame': 'from before anesthesia to after surgery, an anticipated average of 4 hours', 'description': 'level of serum Matrix metallop roteinase before anesthesia and at the end of the surgery'}, {'measure': 'serum S100β', 'timeFrame': 'from before anesthesia to after surgery, an anticipated average of 4 hours', 'description': 'level of serum S100β before anesthesia and at the end of the surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '24256501', 'type': 'RESULT', 'citation': 'Schramm P, Treiber AH, Berres M, Pestel G, Engelhard K, Werner C, Closhen D. Time course of cerebrovascular autoregulation during extreme Trendelenburg position for robotic-assisted prostatic surgery. Anaesthesia. 2014 Jan;69(1):58-63. doi: 10.1111/anae.12477. Epub 2013 Nov 20.'}, {'pmid': '21268573', 'type': 'RESULT', 'citation': 'Pandey R, Garg R, Darlong V, Punj J, Chandralekha, Kumar A. Unpredicted neurological complications after robotic laparoscopic radical cystectomy and ileal conduit formation in steep trendelenburg position: two case reports. Acta Anaesthesiol Belg. 2010;61(3):163-6.'}]}, 'descriptionModule': {'briefSummary': 'This study is to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.', 'detailedDescription': 'During robotic laparoscopic gynecologic surgery, the patients are put in an extremely trendelenburg positon. And a long duration of this position could lead to delayed emergence or agitation. Stimulation at some acupoints were reported to improve homeostasis. In this study we tend to observe whether transcutaneous electrical stimulation at specific acupoints could improve the quality of emergence in patients undergoing robotic laparoscopic gynecologic surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for robotic laparoscopic gynecologic surgery under general anesthesia\n* Patients with written informed consent\n\nExclusion Criteria:\n\n* Patients with difficulty in communication\n* Patients with disease of central nervous system'}, 'identificationModule': {'nctId': 'NCT02323958', 'acronym': 'TIGER', 'briefTitle': 'TEAS to Improve Outcome During Emergence From General Anesthesia After Robotic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Outcome During Emergence From Anesthesia in Patients Undergoing Robotic Laparoscopic Gynecologic Surgery', 'orgStudyIdInfo': {'id': 'XJH-A-2014-6-26-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupoint stimulation', 'description': 'Electrical stimulation is given through electrodes attached to acupoints', 'interventionNames': ['Other: acupoint stimulation', 'Other: electrode attached', 'Device: electrical stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-acupoint stimulation', 'description': 'Electrical stimulation is given through electrodes attached to non-acupoints', 'interventionNames': ['Other: non-acupoint stimulation', 'Other: electrode attached', 'Device: electrical stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control stimulation', 'description': 'Electrode attached but no stimulation is given', 'interventionNames': ['Other: electrode attached']}], 'interventions': [{'name': 'acupoint stimulation', 'type': 'OTHER', 'description': 'stimulation is given at acupoints', 'armGroupLabels': ['Acupoint stimulation']}, {'name': 'non-acupoint stimulation', 'type': 'OTHER', 'description': 'stimulation is given at acupoints', 'armGroupLabels': ['Non-acupoint stimulation']}, {'name': 'electrode attached', 'type': 'OTHER', 'otherNames': ['electrode'], 'description': 'electrodes are attached to skin', 'armGroupLabels': ['Acupoint stimulation', 'Control stimulation', 'Non-acupoint stimulation']}, {'name': 'electrical stimulation', 'type': 'DEVICE', 'description': 'electrical stimulation is given through electrodes attached to th skin', 'armGroupLabels': ['Acupoint stimulation', 'Non-acupoint stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Hailong Dong, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}