Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-02-22 @ 12:03 AM
Study NCT ID:
NCT01912118
Status:
COMPLETED
Last Update Posted:
2015-04-06
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Medasense Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'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'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nociception level index (NoI)', 'timeFrame': 'Between induction and first incision', 'description': 'The NoL measures the magnitude of the autonomic responses to painful stimuli. The NoL combines information from several physiological parameters which represent different autonomic pathways.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular parameters', 'timeFrame': 'Between induction and first incision', 'description': 'Individual pain related cardiovascular parameters, as heart rate, blood pressure and PPG wave amplitude.'}, {'measure': 'Movement', 'timeFrame': 'Between induction and first incision', 'description': 'Visible occurence of movement during painfull stimuli.'}, {'measure': 'Depth of anesthesia', 'timeFrame': 'Between induction and first incision', 'description': 'Depth of anesthesia is measured by a Bispectral Index monitor. Changes in depth of anesthesia will be recorded during painfull stimuli'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nociception', 'General anesthesia'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '22647429', 'type': 'BACKGROUND', 'citation': 'Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.'}, {'pmid': '23835792', 'type': 'BACKGROUND', 'citation': 'Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'Despite various efforts there is still the need for adequate monitoring of pain and nociception during anesthesia. In a previous protocol the investigators measured pain responses during anesthesia based on single end-points, eg heart rate,blood pressure and pulse transit time. None of these parameters provided sufficient information regarding nociception. The investigators therefore want to further investigate this matter using a composite parameter, the Nociception Level or NoL. The NoL is a novel index that measures the magnitude of the autonomic response to painful stimuli. The NoL combines information from several physiological parameters, which represent different autonomic pathways. The multi-parameter approach empowered with state-of-the-art signal processing and machine learning techniques. In the current study the investigators will measure the NoL in ASA 1-3 patients undergoing elective surgery under general anesthesia. The investigators will measure NoL responses and the occurrence of patient movement upon the administration of a painful stimulus: Introduction of the laryngoscope, Insertion of the endotracheal tube, Insertion of the gastric tube, Insertion of the bladder catheter and Skin incision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-80 years;\n* Sex: male or female;\n* Surgery: Any surgery under general anesthesia;\n* ASA status: 1, 2 or 3.\n\nExclusion Criteria:\n\n* Age: \\< 18 or \\> 80 years;\n* Unable to give written informed consent;\n* Pregnancy/lactation;\n* Extreme obesity: BMI \\> 35;\n* Perceived difficult intubation.\n* Patients requiring a rapid sequence induction\n* Patients on beta-blockers'}, 'identificationModule': {'nctId': 'NCT01912118', 'briefTitle': 'The Medasense Study', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'Measurement of Nociceptive Index During General Anesthesia in ASA 1-3 Patients Undergoing Elective Surgery Using the Nociception Level (NoL) Index', 'orgStudyIdInfo': {'id': 'NL43511.058.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PROPOFOL ONLY GROUP', 'description': 'In this study group measurements will be obtained before intubation or opioid administration. To that end plasma propofol concentration will be increased slowly from 0 to 4 μg/ml in steps of 0.5 μg/mL. After the highest target is reached, the propofol target concentration will be lowered to get a BIS value of 50. After 5-min, the laryngoscope will be inserted into the mouth. Next the laryngoscope will be removed. After 5-min the laryngoscope will be placed again and the patient will be intubated. This will be done without additional administration of muscle relaxant.', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL + REMIFENTANIL TARGET A', 'description': 'The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 1 ng/ml remifentanil.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL + REMIFENTANIL TARGET B', 'description': 'The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 2 ng/ml remifentanil', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL + REMIFENTANIL TARGET C', 'description': 'The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 3 ng/ml remifentanil.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL + REMIFENTANIL TARGET D', 'description': 'The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 4 ng/ml remifentanil.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL + REMIFENTANIL TARGET E', 'description': 'The subject will be intubated according to the design of group 1. The propofol concentration will be 2-5 μg/kg, aimed at a BIS of 50, with 5 ng/ml remifentanil.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C', 'description': 'The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS of 30.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}, {'type': 'EXPERIMENTAL', 'label': 'PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C', 'description': 'The subject will be intubated according to the design of group 1. The remifentanil target will be 3 ng/ml remifentanil. The propofol concentration will aim a BIS 70.', 'interventionNames': ['Drug: Propofol', 'Drug: Remifentanil']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)', 'armGroupLabels': ['PROPOFOL + REMIFENTANIL TARGET A', 'PROPOFOL + REMIFENTANIL TARGET B', 'PROPOFOL + REMIFENTANIL TARGET C', 'PROPOFOL + REMIFENTANIL TARGET D', 'PROPOFOL + REMIFENTANIL TARGET E', 'PROPOFOL ONLY GROUP', 'PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C', 'PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C']}, {'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)', 'armGroupLabels': ['PROPOFOL + REMIFENTANIL TARGET A', 'PROPOFOL + REMIFENTANIL TARGET B', 'PROPOFOL + REMIFENTANIL TARGET C', 'PROPOFOL + REMIFENTANIL TARGET D', 'PROPOFOL + REMIFENTANIL TARGET E', 'PROPOFOL TARGET BIS 30 + REMIFENTANIL TARGET C', 'PROPOFOL TARGET BIS 70 + REMIFENTANIL TARGET C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Albert Dahan, MD, PhD, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medasense Biometrics Ltd', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Professor', 'investigatorFullName': 'Albert Dahan', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}