Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT06385756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000654', 'term': 'Amobarbital'}, {'id': 'D015742', 'term': 'Propofol'}], 'ancestors': [{'id': 'D001463', 'term': 'Barbiturates'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial pressure (MAP) during Induction of anesthesia', 'timeFrame': 'Up to 3 hours', 'description': 'MAP was recorded as the main index of hemodynamics during anesthesia induction'}], 'secondaryOutcomes': [{'measure': 'MAP at different time points', 'timeFrame': 'Up to 3 hours', 'description': 'MAP at different time points (including before induction, tracheal intubation, cutting the skin, extubation)'}, {'measure': 'Incidence of postoperative nausea and vomiting (ponv)', 'timeFrame': '24 hours', 'description': 'The incidence of perioperative adverse reactions (ponv) was recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia induction', 'Perioperative Adverse Reactions', 'Gynecological Laparoscopic Surgery'], 'conditions': ['Amobarbital Sodium', 'Hemodynamics Instability']}, 'descriptionModule': {'briefSummary': 'At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.\n\nThe main questions it aims to answer are:\n\n* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;\n* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.\n\nParticipants will:\n\n* Induction of anesthesia with the experimental drug or placebo；\n* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；\n* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40\\~60 years old；\n* ASA Class I to II；\n* The operation time was 1h\\~2h；\n* BMI 18\\~25；\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Known allergy to narcotic drugs used in this study;\n* Severe pulmonary insufficiency;\n* Abnormal liver and kidney function；\n* History of severe anemia and hematoporphyrin；\n* History of asthma;\n* Uncontrolled high blood pressure or diabetes;\n* Pregnant and lactating women；\n* Accompanied by cognitive impairment or inability to communicate.'}, 'identificationModule': {'nctId': 'NCT06385756', 'briefTitle': 'Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'TJ-IRB202403020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'amobarbital-propofol group', 'description': 'Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.', 'interventionNames': ['Drug: Amobarbital', 'Drug: Propofol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'propofol group', 'description': 'The propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg.', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Amobarbital', 'type': 'DRUG', 'description': 'Participants with gynecological laparoscopic surgery who met the trial inclusion criteria were randomly divided into 2 groups. After entering the room, peripheral intravenous infusion was opened and oxygen was absorbed by the mask for 5 L/min. Mean arterial pressure, heart rate and oxygen saturation were routinely monitored. After positioning, the amobarbital-propofol group was given amobarbital sodium 1 mg/kg 1 min before induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 1.5mg /kg for general anesthesia induction. The propofol group was given the same volume of normal saline 1 min before anesthesia induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 2.5mg /kg.', 'armGroupLabels': ['amobarbital-propofol group']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'propofol', 'armGroupLabels': ['amobarbital-propofol group', 'propofol group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xuebi Tian', 'investigatorAffiliation': 'Tongji Hospital'}}}}