Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT06867302
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2025-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine and Agitation After Nasal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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'], 'maskingDescription': 'Apart from the anesthesiologists who performed the blocks, all patients, surgeons, and postoperative nurses remained blinded to randomization throughout the study period.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the patients will be randomly allocated into two groups based on a computerized randomization table created by a researcher who was not involved in the study. The researcher assigned a random ID to each patient, and a blinded anesthesiologist used this ID while collecting the postoperative data in the surgical ward.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': '5 minutes before entering operation department', 'description': 'in years'}, {'measure': 'Sex', 'timeFrame': '5 minutes before entering operation department', 'description': 'Male of female'}, {'measure': 'Weight', 'timeFrame': '5 minutes before entering operation department', 'description': 'In kilogram'}, {'measure': 'Height', 'timeFrame': '5 minutes before entering operation department', 'description': 'In centimeter'}, {'measure': 'Duration of surgery', 'timeFrame': '5 minutes after end of surgery', 'description': 'In minutes'}], 'primaryOutcomes': [{'measure': 'Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)', 'timeFrame': '5 minutes after operation', 'description': "RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation"}], 'secondaryOutcomes': [{'measure': 'Intraoperative heart rate', 'timeFrame': 'Every 15 minutes along operation', 'description': 'Beats / minute'}, {'measure': 'Intraoperative mean arterial blood pressure', 'timeFrame': 'Every 15 minutes along operation', 'description': 'mmHg'}, {'measure': 'Time of first rescue analgesic', 'timeFrame': '5 minutes before first analgesic request', 'description': 'in minutes in minutes'}, {'measure': 'Extubation time', 'timeFrame': '3 minutes after removal of endotracheal tube', 'description': 'time interval between shutting off anesthetics to extubation (in minutes)'}, {'measure': 'Postanesthesia care unit time', 'timeFrame': '5 minutes after discharge from recovery unit', 'description': 'time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge)'}, {'measure': 'Incidence of use of midazolam', 'timeFrame': '2 minutes after occurence of emergence agitation', 'description': 'Yes or no'}, {'measure': 'Numerical rating score (NRS)', 'timeFrame': 'Every 10 min in postanesthesia care unit', 'description': '10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable"'}, {'measure': 'Total amount of rescue analgesic', 'timeFrame': '24 hours postoperative', 'description': 'in milligram'}, {'measure': 'Boezaart Surgical Field Grading Scale', 'timeFrame': '2 hours intraoperatively', 'description': 'endoscopically using the six-point score (0-5 Scale) where 0 - No bleeding, 1 - Slight bleeding, no suctioning needed, 2 - Slight bleeding, occasional suctioning needed, 3 - Moderate bleeding, frequent suctioning needed, visibility maintained, 4 - Heavy bleeding, constant suctioning needed, visibility impaired, 5 - Severe bleeding, uncontrolled, surgery impossible'}, {'measure': 'Incidence of bradycardia', 'timeFrame': '2 hours intraoperatively', 'description': 'Yes or no'}, {'measure': 'Incidence of hypotension', 'timeFrame': '2 hours intraoperatively', 'description': 'Yes or no when mean arterial blood pressure below 60 mmHg'}, {'measure': 'Incidence of nausea', 'timeFrame': '24 hours postoperative', 'description': 'Yes or no'}, {'measure': 'Incidence of vomiting', 'timeFrame': '24 hours postoperative', 'description': 'Yes or no'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Emergence agitation', 'Nasal surgery'], 'conditions': ['Nasal Disease', 'Agitation, Emergence']}, 'referencesModule': {'references': [{'pmid': '20526708', 'type': 'BACKGROUND', 'citation': 'Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.'}, {'pmid': '19326585', 'type': 'BACKGROUND', 'citation': 'Hudek K. Emergence delirium: a nursing perspective. AORN J. 2009 Mar;89(3):509-16; quiz 517-9. doi: 10.1016/j.aorn.2008.12.026.'}, {'pmid': '25729495', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Kim DK, Kim HY, Kim JK, Choi SW. Risk factors of emergence agitation in adults undergoing general anesthesia for nasal surgery. Clin Exp Otorhinolaryngol. 2015 Mar;8(1):46-51. doi: 10.3342/ceo.2015.8.1.46. Epub 2015 Feb 3.'}, {'pmid': '16670111', 'type': 'BACKGROUND', 'citation': 'Lepouse C, Lautner CA, Liu L, Gomis P, Leon A. Emergence delirium in adults in the post-anaesthesia care unit. Br J Anaesth. 2006 Jun;96(6):747-53. doi: 10.1093/bja/ael094. Epub 2006 May 2.'}, {'pmid': '25874562', 'type': 'BACKGROUND', 'citation': 'Zhu M, Wang H, Zhu A, Niu K, Wang G. Meta-analysis of dexmedetomidine on emergence agitation and recovery profiles in children after sevoflurane anesthesia: different administration and different dosage. PLoS One. 2015 Apr 13;10(4):e0123728. doi: 10.1371/journal.pone.0123728. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.', 'detailedDescription': 'Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.\n\ndexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.\n\nNevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.\n\nNo premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.\n\nWhen surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.\n\nStatistical analysis:\n\nStatistical analysis will be conducted using IBM SPSS Statistics 22 (IBM Corporation, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p \\< 0.05 will be deemed to be statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologist (ASA) Ⅰ or II\n* Adults with body mass index (BMI) \\< 30 Kg/m\n* Underwent elective nasal surgery.\n\nExclusion Criteria:\n\n* Significant comorbidity like hepatic, renal, or cardiac disease\n* Auditory impairment\n* Cognitive dysfunction\n* Substance abuse\n* Allergy to the studied medicines\n* Planned intensive care admission after the surgery.'}, 'identificationModule': {'nctId': 'NCT06867302', 'briefTitle': 'Dexmedetomidine and Agitation After Nasal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University Hospital'}, 'officialTitle': 'Effectiveness of Single Bolus Versus Continuous Infusion of Dexmedetomidine in Mitigating Agitation in Adults Undergoing Nasal Surgery: a Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'R656'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bolus group', 'description': 'single dose 0.5 µg/kg in 15 ml saline over 10 min , started 15 minutes before end of surgery', 'interventionNames': ['Drug: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)']}, {'type': 'EXPERIMENTAL', 'label': 'Infusion group', 'description': 'Infusion of dexmedetomidine at a dose of 0.5 µg/kg/h without loading dose all through intraoperative time', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}], 'interventions': [{'name': 'Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine infusion'], 'description': 'An infusion given all through intraoperative time', 'armGroupLabels': ['Bolus group']}, {'name': 'Dexmedetomidine Injection [Precedex]', 'type': 'DRUG', 'otherNames': ['Dexmedetomidine bolus'], 'description': 'Single dose given 15 minutes before end of surgery', 'armGroupLabels': ['Infusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63514', 'city': 'Al Fayyum', 'state': 'Faiyum Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Yasser S Mostafa, MD.', 'role': 'CONTACT', 'email': 'ysm03@fayoum.edu.eg', 'phone': '01010509735', 'phoneExt': '+2'}, {'name': 'Mohamed A Shawky, MD', 'role': 'CONTACT', 'email': 'mas14@fayoum.edu.eg', 'phone': '01095254547', 'phoneExt': '+2'}], 'facility': 'Fayoum University Hospital', 'geoPoint': {'lat': 29.30995, 'lon': 30.8418}}], 'centralContacts': [{'name': 'Yasser S Mostafa, MD', 'role': 'CONTACT', 'email': 'ysm03@fayoum.edu.eg', 'phone': '01010509735', 'phoneExt': '+2'}, {'name': 'Mohamed A Shawky, MD', 'role': 'CONTACT', 'email': 'mas14@fayoum.edu.eg', 'phone': '0 109 525 4547', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Yasser S Mostafa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fayoum University'}, {'name': 'Mohamed A Shawky, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Fayoum University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology', 'investigatorFullName': 'Yasser S Mostafa, MD', 'investigatorAffiliation': 'Fayoum University Hospital'}}}}