Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-30 @ 2:29 AM
Study NCT ID:
NCT00850850
Status:
UNKNOWN
Last Update Posted:
2010-05-27
First Post:
2009-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physostigmine After General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010830', 'term': 'Physostigmine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2009-02-24', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The readiness to be released from the PACU (assessed by the normal guidelines) It should be noted that for safety reasons the patients remained in the PACU for at least 60 minutes', 'timeFrame': '60 minutes'}], 'secondaryOutcomes': [{'measure': 'Pain, shivering and nausea will also be registered on the standardized form as well as a multiple of physiological measurements. A follow-up will be performed after 12 hours from release from the PACU', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PACU', 'Physostigmine', 'Recovery', 'Postanesthesia Nursing', 'Wakefulness', 'General anesthesia', 'General Anesthetics', 'Postoperative Period'], 'conditions': ['Postoperative Nausea and Vomiting', 'Anesthesia Recovery Period']}, 'descriptionModule': {'briefSummary': 'Recovery after general anaesthesia is often prolonged in the elderly. This group is particularly exposed to post-operative confusion. This has negative personal consequences as well as consequences for the postoperative care for these patients.\n\nThe hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative confusion.', 'detailedDescription': 'The researchers wish to investigate the use of physostigmine in the elderly patients (age \\> 60 yrs, ASA I-III) in the postoperative recovery-phase after general anesthesia.\n\nApart from the beneficial effects for the patient, the lessened amount of time in the PACU will release caregiving resources and thereby increase the efficacy of the PACU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Scheduled for surgical acute or elective operation\n* General anesthesia.\n* ASA physical status I-III\n* Age \\> 60 years\n\nExclusion Criteria:\n\n* Asthma and chronic pulmonary diseases\n* Glaucoma\n* Diabetics\n* Any history of neurological and psychiatric disorder\n* Parkinson's disease\n* Disorders of the gastrointestinal and urogenital tracts"}, 'identificationModule': {'nctId': 'NCT00850850', 'briefTitle': 'Physostigmine After General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia', 'orgStudyIdInfo': {'id': '2006-002497-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Physostigmine', 'description': 'Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 mg of physostigmine.', 'interventionNames': ['Drug: physostigmine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl', 'description': 'Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo).', 'interventionNames': ['Drug: Isotonic sodium chloride solution']}], 'interventions': [{'name': 'physostigmine', 'type': 'DRUG', 'otherNames': ['Fysostigmin; Methylcarbamate; Erserine; Eserolein'], 'description': '1 mg of physostigmine time 0 min. If the condition persisted after 15 min. the same amount of active drug would be administered once again.', 'armGroupLabels': ['Physostigmine']}, {'name': 'Isotonic sodium chloride solution', 'type': 'DRUG', 'otherNames': ['NaCl'], 'description': 'Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo) time 0 min. If the condition persisted after 15 min. the same amount of non-active drug would be administered once again.', 'armGroupLabels': ['NaCl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Copenhagen NV', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Carsten M Pedersen, cand.cur.', 'role': 'CONTACT', 'email': 'cped0070@bbh.regionh.dk', 'phone': '+4535313983'}], 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Frank Pott, MD', 'role': 'CONTACT', 'email': 'frank.pott@gmail.com', 'phone': '+4535313531', 'phoneExt': '4358'}, {'name': 'Carsten M Pedersen, MSN', 'role': 'CONTACT', 'email': 'carstenmp@hotmail.com', 'phone': '+4535313983', 'phoneExt': '4845'}], 'overallOfficials': [{'name': 'Frank Pott, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Frank Pott', 'oldOrganization': 'ICU'}}}}