Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-28 @ 11:00 PM
Study NCT ID:
NCT04529135
Status:
COMPLETED
Last Update Posted:
2022-06-23
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "Patients are divided into the Dexmedetomidine group / control group by random assignment. Using a table of computer-generated random numbers(s), assign 68 people to each county by 34 people. Random tables, in turn, seal the results in an opaque envelope. An anesthesiologist who is unaware of the content of this study and does not participate in the study receives information only about drug administration and is in charge of anesthesia, and does not disclose information about the assigned group to postoperative observers. Also, they don't disclose information about the assigned group to the surgeon."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Double-blind Controlled Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative recovery time', 'timeFrame': '3 months', 'description': 'number of days satisfying all following criteria 1)intestinal gas passage 2) tolerance of soft bland diet (SBD) for 24 hr. 3) safe ambulation without assistance 4) no requirement iv analgesics after discontinuation of PCA (VAS \\<4). 5) no abnormal physical signs or laboratory test.'}], 'secondaryOutcomes': [{'measure': 'maximum pain score', 'timeFrame': '3 months', 'description': 'Visual analogue scale (VAS: 0-10)'}, {'measure': 'post-operative hospital stay', 'timeFrame': '3 months', 'description': 'days'}, {'measure': 'complications and readmission rate at 3 months F/U time', 'timeFrame': '3 months', 'description': 'incidence'}, {'measure': 'post-operative period analgesic requirement', 'timeFrame': '3 months', 'description': 'number of analgesic requirement despite intravenous patient controlled analgesia'}, {'measure': 'opioid related side effect.', 'timeFrame': '3 months', 'description': 'incidence of nausea, vomiting and pruritus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': '"Want to know the effect of dexmedetomidine during opioid free anesthesia on postoperative recovery after gastrectomy. Patients undergoing open gastrectomy are divided into dexmedetomidine group and control(remifentanil) group, administered during surgery, and compared with the speed of postoperative intestinal function recovery. Based on our institution\'s previous record, the average recovery time was 6 ± 1.4 days. Given that it is clinically significant to reduce recovery time by 20%, Alpha 0.05 and Power 80% require 31 samples per group, and assuming a 10% dropout rate, the total number of samples needed is 68.Subjects are patients aged 19 to 75 who are subject to open gastretomy planned by a gastric cancer. The exclusion criteria include American Society of Anesthesiology grade 3 or higher, patients who have previously been treated for cancer, patients with cancer other than the stomach, patients with drug allergies, weight less than 60kg, BMI \\> 30 kg/m2, patients who are unable to communicate and are unable to read consent (e.g., illiteracy, foreigners, etc.). The research method is a Randomized double-blind controlled study, and the assignment of both drugs is unknown and is used to maintain anesthesia in the form of continuous injection during surgery. Primary outcome is the recovery period satisfying the following. 1)intestinal gas passage 2) tolerance of soft bland diet (SBD) for 24 hr. 3) safe ambulation without assistance 4) no requirement iv analgesics after discontinuation of PCA (VAS \\<4). 5) no abnormal physical signs or laboratory test. The secondary outcomes are maximum VAS, post-operative hospital stay, complications and readmission rate at 3 months F/U time, post-operative period analgesic requirement, incidence of opioid related side effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-patients undergoing open gastrectomy for gastric cancer\n\nExclusion Criteria:\n\n* American Society of Anesthesiology grade 3 or higher\n* history of chemotherapy\n* diagosis of cancer in other organs\n* history of drug allergy\n* weight less than 60kg\n* BMI over 30 kg/m2 patient\n* cognitive impairment\n* gait disturbance'}, 'identificationModule': {'nctId': 'NCT04529135', 'briefTitle': 'The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'The Effect of Dexmedetomidine During Opioid Free Anesthesia on Postoperative Recovery After Gastrectomy : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020-0219-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'IV,0.2\\~0.8 µg/kg/hr', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'IV,0.05\\~0.2 µg/kg/min', 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'The prepared drug marks the assigned group as unknown. In both groups, the test drug marked as unknown begins to be administered in an anesthetic induction. When the patient arrives in the operating room, electrocardiogram, noninvasive blood pressure, and bispectral index (BIS) monitoring is performed. In both groups, 2 mg/kg of propofol induces general anesthesia, intubates after administration of rocuronium 0.6 mg/kg, and maintains anesthesia with sevoflurane 1.5-2.5 vol%. Use 0.075 mg of palonosetrone as an antiemetics after inducing anesthesia. Adjust the inhalation anesthetic to maintain BIS 40-60 , mechanical ventilation to maintain the Tidal volume of 8 ml/kg, PEEP 5 mmHg and end-tidal carbon dioxide (EtCO2) of 35-40 mmHg. Push 1mcg of fentanyl and 1g of acetaminophen per kg for pain control 20 minutes before the end of surgery.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Remifentanil', 'type': 'DRUG', 'description': 'The prepared drug marks the assigned group as unknown. In both groups, the test drug marked as unknown begins to be administered in an anesthetic induction. When the patient arrives in the operating room, electrocardiogram, noninvasive blood pressure, and bispectral index (BIS) monitoring is performed. In both groups, 2 mg/kg of propofol induces general anesthesia, intubates after administration of rocuronium 0.6 mg/kg, and maintains anesthesia with sevoflurane 1.5-2.5 vol%. Use 0.075 mg of palonosetrone as an antiemetics after inducing anesthesia. Adjust the inhalation anesthetic to maintain BIS 40-60 , mechanical ventilation to maintain the Tidal volume of 8 ml/kg, PEEP 5 mmHg and end-tidal carbon dioxide (EtCO2) of 35-40 mmHg. Push 1mcg of fentanyl and 1g of acetaminophen per kg for pain control 20 minutes before the end of surgery.', 'armGroupLabels': ['Remifentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Ji-young Kim', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}