Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-25 @ 5:48 PM
Study NCT ID:
NCT04089592
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2019-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patient meeting the inclusion criteria will be randomly allocated divided into two groups by chit paper method A, B (30 participants in each group).'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RCT, Double-blind, Randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-21', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'at Baseline', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Systolic blood pressure', 'timeFrame': '0 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Systolic blood pressure', 'timeFrame': '1 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Systolic blood pressure', 'timeFrame': '3 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Systolic blood pressure', 'timeFrame': '5 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Systolic blood pressure', 'timeFrame': '10 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'at Baseline', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '0 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'at 1 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'at 3 minutes', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'at 5 minutes', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Diastolic blood pressure', 'timeFrame': 'at 10 minutes', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Heart rate', 'timeFrame': 'at Baseline', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Heart rate', 'timeFrame': 'at 0 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Heart rate', 'timeFrame': 'at 1 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Heart rate', 'timeFrame': 'at 3 minutes', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Heart rate', 'timeFrame': '5 minutes', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Heart rate', 'timeFrame': 'at 10 minutes', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Mean atrial pressure', 'timeFrame': 'at Baseline', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Mean atrial pressure', 'timeFrame': 'at 0 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Mean atrial pressure', 'timeFrame': 'at 1 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Mean atrial pressure', 'timeFrame': 'at 3 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Mean atrial pressure', 'timeFrame': 'at 5 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'Mean atrial pressure', 'timeFrame': 'at 10 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'SpO (oxygen saturation)', 'timeFrame': 'at Baseline', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'SpO (oxygen saturation)', 'timeFrame': 'at 0 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'SpO (oxygen saturation)', 'timeFrame': 'at 1 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'SpO (oxygen saturation)', 'timeFrame': 'at 3 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'SpO (oxygen saturation)', 'timeFrame': 'at 5 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}, {'measure': 'SpO (oxygen saturation)', 'timeFrame': 'at 10 minute', 'description': 'Hemodynamic response(induction) will be assessed on different point in time during procedure'}], 'secondaryOutcomes': [{'measure': 'Ramsey score', 'timeFrame': 'at arrival', 'description': 'Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response'}, {'measure': 'Ramsey score', 'timeFrame': 'at 10 minutes', 'description': 'Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response'}, {'measure': 'Aldrete score', 'timeFrame': 'at arrival', 'description': 'Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery'}, {'measure': 'Aldrete score', 'timeFrame': 'at 10 min', 'description': 'Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery'}, {'measure': 'Complications', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}, {'measure': 'Laryngospasm', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}, {'measure': 'Bradycardia', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}, {'measure': 'Regurgitation', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}, {'measure': 'Post operative vomiting and nausea', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}, {'measure': 'Hypertension', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}, {'measure': 'Hypotension', 'timeFrame': 'Will be assessed within Hospital stay at follow for 1 week', 'description': 'Post operative complication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Cholecystectomy', 'Dexmedetomidine', 'Fentanyl', 'Hemodynamics response', 'Direct laryngoscopy', 'Intubation'], 'conditions': ['Cholecystectomy', 'Elective Surgery']}, 'referencesModule': {'references': [{'pmid': '29207810', 'type': 'RESULT', 'citation': 'Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy.\n\nCompare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients.\n\nDexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no research work available at the national level and scarcity of data at an international level with inconclusive outcomes. Our participation in the form of this research will add to scientific literature and step up ahead at the international level.\n\nFentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic value is analgesia and sedation. It is extensively used for anesthetic and analgesic most often in operating room and ICU.', 'detailedDescription': "This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA-I and ll patients\n2. Male and female patient of age 20-70 years.\n3. Undergoing Elective laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\n1. Pregnant and lactating females\n2. Short thick neck with anticipated difficult intubation.\n3. Obese patients.\n4. Narcotic addicts.\n5. Full stomach patient or with higher chances of aspiration.\n6. Patient allergic to any of the study medications.\n7. Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications.'}, 'identificationModule': {'nctId': 'NCT04089592', 'briefTitle': 'Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.', 'orgStudyIdInfo': {'id': 'SUrooj'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dex Group', 'description': 'intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Fent Group', 'description': 'intravenous fentanyl at 2mcg/kg in 100ml saline', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Fentanyl'], 'description': 'intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%', 'armGroupLabels': ['Dex Group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine'], 'description': 'intravenous fentanyl at 2mcg/kg in 100ml saline', 'armGroupLabels': ['Fent Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75520', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Civil Hospital Karachi', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '75520', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'DUHS, Civil hospital Karachi (CHK)', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Sana Urooj, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Ruth K.M. Pfau Civil Hospital, Karachi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sana Urooj', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}