Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-12 @ 10:49 PM
Study NCT ID:
NCT01871935
Status:
UNKNOWN
Last Update Posted:
2014-01-31
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005283', 'term': 'Fentanyl'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-30', 'studyFirstSubmitDate': '2013-05-30', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CO', 'timeFrame': 'During anaesthesia'}], 'secondaryOutcomes': [{'measure': 'MAP', 'timeFrame': 'During anaesthesia'}, {'measure': 'Tissue oxygen saturation', 'timeFrame': 'During anaesthesia'}, {'measure': 'CO', 'timeFrame': 'During anaesthesia', 'description': 'CO obtained by different devices/methods (i.e. the Vigileo device and TEE)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Haemodynamic Fluctuations During Off-pump CABG.']}, 'referencesModule': {'references': [{'pmid': '33028197', 'type': 'DERIVED', 'citation': 'Poterman M, Kalmar AF, Buisman PL, Struys MMRF, Scheeren TWL. Improved haemodynamic stability and cerebral tissue oxygenation after induction of anaesthesia with sufentanil compared to remifentanil: a randomised controlled trial. BMC Anesthesiol. 2020 Oct 7;20(1):258. doi: 10.1186/s12871-020-01174-9.'}]}, 'descriptionModule': {'briefSummary': 'Induction of general anaesthesia with a combination of opiates and hypnotics often induces vasodilation resulting in several haemodynamic effects such as a decrease in blood pressure (MAP), heart rate (HR) and cardiac output (CO). This haemodynamic suppression may jeopardize tissue oxygenation, particularly cerebral oxygenation. Previous research of the investigators group has revealed that atropine has an exceptionally beneficial effect on the determinants of tissue oxygen delivery as well as on tissue oxygenation. The investigators have demonstrated a significant and clinically relevant increase in CO and cerebral tissue oxygenation (SctO2) for a desired increase in MAP. This is in steep contrast with the more usual clinical practice of administrating classical vasoactive medication such as phenylephrine or norepinephrine, since the two latter have an even negative effect on CO and SctO2. In previous research the investigators used standardized target controlled propofol/remifentanil infusions for induction and maintenance of anaesthesia. It is known that remifentanil has more intense haemodynamic side-effects compared to other opiates such as fentanyl, sufentanil or alfentanil. This raises the question whether the beneficial effect of atropine is restricted to propofol/remifentanil anaesthesia, or if this is equally valid during anaesthesia of propofol combined with other opiates such as sufentanil.\n\nPatients undergoing off-pump coronary artery bypass grafting (CABG) require a long and deep general anaesthesia, which is usually performed with the combination of drugs as mentioned above. Because these patients often experience severe haemodynamic fluctuations they need to be closely monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 years and older.\n* Elective CABG surgery performed off-pump.\n* Written informed consent to participate in this study.\n* Patient and surgical procedure appropriate for treatment with either sufentanil or remifentanil.\n\nExclusion Criteria:\n\n* Refusal to participate in this study.\n* Age: younger than 18 years.\n* Pregnant.\n* BMI \\> 35 kg/m2.\n* Patients in which atropine is contra-indicated.\n* Patients in which sufentanil or remifentanil at the proposed doses are contra-indicated.\n* Urgent or emergency surgery.'}, 'identificationModule': {'nctId': 'NCT01871935', 'briefTitle': 'Atropine Effects in Anaesthesia With Sufentanil vs. Remifentanil', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Comparison of the Effects of Atropine on Haemodynamics and Tissue Oxygenation in Anaesthesia With Propofol and Sufentanil Versus Propofol and Remifentanil', 'orgStudyIdInfo': {'id': 'SuRe-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remifentanil', 'description': 'Anaesthesia with remifentanil/propofol', 'interventionNames': ['Drug: Remifentanil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sufentanil', 'description': 'Anaesthesia with sufentanil/propofol', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'description': 'Anaesthesia with remifentanil/propofol.', 'armGroupLabels': ['Remifentanil']}, {'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Anaesthesia with sufentanil/propofol', 'armGroupLabels': ['Sufentanil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'state': 'Provincie Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rob Spanjersberg', 'role': 'CONTACT', 'email': 'r.spanjersberg@umcg.nl'}, {'name': 'Alain F Kalmar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Alain F Kalmar, MD, PhD', 'role': 'CONTACT', 'email': 'a.f.kalmar@umcg.nl'}], 'overallOfficials': [{'name': 'Alain F Kalmar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'A.F.Kalmar', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}