Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-25 @ 7:56 AM
Study NCT ID:
NCT02351557
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2015-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Effect of Cardiac Output on the Uptake of Isoflurane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-01', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of isoflurane in milliliter of vapor per minute', 'timeFrame': 'Every minute from 1 to 30 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '8669560', 'type': 'BACKGROUND', 'citation': 'Watt SJ, Cook LB, Ohri S, Lockwood GG. The relationship between anaesthetic uptake and cardiac output. Anaesthesia. 1996 Jan;51(1):24-8. doi: 10.1111/j.1365-2044.1996.tb07648.x.'}, {'pmid': '1609936', 'type': 'BACKGROUND', 'citation': 'Myles PS, Storer R, Millar C. Haemodynamic effects and uptake of enflurane in patients undergoing cardiac surgery: good versus poor myocardial function. Anaesth Intensive Care. 1992 Feb;20(1):21-7. doi: 10.1177/0310057X9202000104.'}, {'pmid': '11703234', 'type': 'BACKGROUND', 'citation': 'Kennedy RR, Baker AB. The effect of cardiac output changes on end-expired volatile anaesthetic concentrations--a theoretical study. Anaesthesia. 2001 Nov;56(11):1034-40. doi: 10.1046/j.1365-2044.2001.02212.x.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the effect of blood flow through the lungs and the body on the consumption and hence requirement of the anesthetic agent isoflurane.', 'detailedDescription': 'The effect of cardiac output on the uptake of isoflurane is yet to be quantified. This study aims to obtain a quantifiable relationship between isoflurane uptake and cardiac output. The study patients will be cardiac patients in whom anesthesia is induced with fentanyl , propofol and maintained on isoflurane . The baseline cardiac index from the pulmonary artery catheter as displayed on the continuous cardiac output monitor will be used to classify the patients into two groups with cardiac index of 2.1 liters per minute per square meter as the differentiating criteria. No change in the anesthesia protocol will be done for the two groups.The study is designed such that all vascular catheterisations and the dose of isoflurane administered is as per prevailing institutional protocols and that no other intervention particular or unique to the study is done. As such the data that the study will use is also routinely acquired during the procedure but not systematically stored, which is what the study will do. This, we suggest, makes the study an observational study.The continuous cardiac output data and the inspired and expired concentration of isoflurane as displayed on the monitor will be recorded online. Data will be collected from the start of isoflurane till 30 minutes or till the surgeon starts cannulating the great vessels. The data so obtained will be analysed in two groups based on the baseline cardiac index using Statistical Package for the Social Sciences (SPSS) for difference in uptake between the groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing elective, open cardiac procedures under general endotracheal anesthesia with cardiopulmonary bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of valve stenosis / valvular regurgitant lesion/ coronary artery disease with Ejection fraction \\>40%\n* Posted for open cardiac surgery under general endotracheal anesthesia\n\nExclusion Criteria:\n\n* Shunt lesion\n* Allergy to propofol\n* Psychotropic drug use\n* Preinduction hemodynamic instability'}, 'identificationModule': {'nctId': 'NCT02351557', 'briefTitle': 'Pharmacokinetic Study of Effect of Cardiac Output on the Uptake of Isoflurane', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'Effect of Cardiac Output on Uptake of Isoflurane', 'orgStudyIdInfo': {'id': '9151/PG-2Trg/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reference', 'description': 'Baseline cardiac index more than or equal to 2.1 liters per minute per square meter'}, {'label': 'Low cardiac output', 'description': 'Baseline cardiac index less than 2.1 liters per minute per square meter'}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'GOVERDHAN D PURI, MD,Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, {'name': 'Rajarajan Ganesan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, {'name': 'Aveek Jayant, M.D.,D.M.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, {'name': 'Shyam Thingnam, M.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Resident', 'investigatorFullName': 'Rajarajan Ganesan', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}