Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT05772832
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2023-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2023-02-18', 'studyFirstSubmitQcDate': '2023-03-06', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain scale', 'timeFrame': 'at post anesthesia care unit (T1)', 'description': 'Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )'}, {'measure': 'postoperative pain scale', 'timeFrame': '2 hours after surgery (T2)', 'description': 'Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )'}, {'measure': 'postoperative pain scale', 'timeFrame': '8 hours after surgery (T3)', 'description': 'Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )'}, {'measure': 'postoperative pain scale', 'timeFrame': '24 hours after surgery (T4)', 'description': 'Comparison of postoperative Numerical Rating Scale(NRS) values of both study arms(min 0, max 10; 10 is unbearable pain )'}], 'secondaryOutcomes': [{'measure': 'need for analgesics', 'timeFrame': 'Additional analgesic drug requirements at post anesthesia care unit (T1)', 'description': 'Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication'}, {'measure': 'need for analgesics', 'timeFrame': 'Additional analgesic drug requirements at 2 hours after surgery (T2)', 'description': 'Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication'}, {'measure': 'need for analgesics', 'timeFrame': 'Additional analgesic drug requirements at 8 hours after surgery (T3)', 'description': 'Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication'}, {'measure': 'need for analgesics', 'timeFrame': 'Additional analgesic drug requirements at 24 hours after surgery (T4)', 'description': 'Comparison of whether there is a need for additional POSTOPERATIVE analgesic medication'}, {'measure': 'Comparison of postoperative nausea-vomiting rate', 'timeFrame': 'at post anesthesia care unit (T1)', 'description': 'Comparison of postoperative nausea-vomiting rate'}, {'measure': 'Comparison of postoperative nausea-vomiting rate', 'timeFrame': '2 hours after surgery (T2)', 'description': 'Comparison of postoperative nausea-vomiting rate'}, {'measure': 'Comparison of postoperative nausea-vomiting rate', 'timeFrame': '8 hours after surgery (T3)', 'description': 'Comparison of postoperative nausea-vomiting rate'}, {'measure': 'Comparison of postoperative nausea-vomiting rate', 'timeFrame': '24 hours after surgery (T4)', 'description': 'Comparison of postoperative nausea-vomiting rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DEXMEDETOMİDİNE', 'REMİFENTANYL', 'pituitary SURGERY'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '22301064', 'type': 'BACKGROUND', 'citation': 'Zheng Y, Cui S, Liu Y, Zhang J, Zhang W, Zhang J, Gu X, Ma Z. Dexmedetomidine prevents remifentanil-induced postoperative hyperalgesia and decreases spinal tyrosine phosphorylation of N-methyl-d-aspartate receptor 2B subunit. Brain Res Bull. 2012 Mar 10;87(4-5):427-31. doi: 10.1016/j.brainresbull.2012.01.009. Epub 2012 Jan 25.'}, {'pmid': '23646238', 'type': 'BACKGROUND', 'citation': 'Lee C, Kim YD, Kim JN. Antihyperalgesic effects of dexmedetomidine on high-dose remifentanil-induced hyperalgesia. Korean J Anesthesiol. 2013 Apr;64(4):301-7. doi: 10.4097/kjae.2013.64.4.301. Epub 2013 Apr 22.'}, {'pmid': '11056756', 'type': 'BACKGROUND', 'citation': 'Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.'}, {'pmid': '2900154', 'type': 'BACKGROUND', 'citation': 'Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14. doi: 10.1016/0014-2999(88)90744-3.'}, {'pmid': '25750586', 'type': 'BACKGROUND', 'citation': 'Hwang W, Lee J, Park J, Joo J. Dexmedetomidine versus remifentanil in postoperative pain control after spinal surgery: a randomized controlled study. BMC Anesthesiol. 2015 Feb 24;15:21. doi: 10.1186/s12871-015-0004-1. eCollection 2015.'}, {'pmid': '30009153', 'type': 'BACKGROUND', 'citation': 'Javaherforooshzadeh F, Monajemzadeh SA, Soltanzadeh M, Janatmakan F, Salari A, Saeed H. A Comparative Study of the Amount of Bleeding and Hemodynamic Changes between Dexmedetomidine Infusion and Remifentanil Infusion for Controlled Hypotensive Anesthesia in Lumbar Discopathy Surgery: A Double-Blind, Randomized, Clinical Trial. Anesth Pain Med. 2018 Apr 28;8(2):e66959. doi: 10.5812/aapm.66959. eCollection 2018 Apr.'}, {'pmid': '26325514', 'type': 'BACKGROUND', 'citation': 'Rajan S, Hutcherson MT, Sessler DI, Kurz A, Yang D, Ghobrial M, Liu J, Avitsian R. The Effects of Dexmedetomidine and Remifentanil on Hemodynamic Stability and Analgesic Requirement After Craniotomy: A Randomized Controlled Trial. J Neurosurg Anesthesiol. 2016 Oct;28(4):282-90. doi: 10.1097/ANA.0000000000000221.'}, {'pmid': '28580080', 'type': 'BACKGROUND', 'citation': 'Choi EK, Seo Y, Lim DG, Park S. Postoperative nausea and vomiting after thyroidectomy: a comparison between dexmedetomidine and remifentanil as part of balanced anesthesia. Korean J Anesthesiol. 2017 Jun;70(3):299-304. doi: 10.4097/kjae.2017.70.3.299. Epub 2017 Mar 15.'}, {'pmid': '26512563', 'type': 'BACKGROUND', 'citation': 'Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Colectomy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Medicine (Baltimore). 2015 Oct;94(43):e1727. doi: 10.1097/MD.0000000000001727.'}, {'pmid': '19139778', 'type': 'BACKGROUND', 'citation': 'Salman N, Uzun S, Coskun F, Salman MA, Salman AE, Aypar U. Dexmedetomidine as a substitute for remifentanil in ambulatory gynecologic laparoscopic surgery. Saudi Med J. 2009 Jan;30(1):77-81.'}, {'pmid': '32009708', 'type': 'BACKGROUND', 'citation': 'Hamed JME, Refaat HSM, Al-Wadaani H. Dexmedetomidine Compared to Remifentanil Infusion as Adjuvant to Sevoflurane Anesthesia during Laparoscopic Sleeve Gastrectomy. Anesth Essays Res. 2019 Oct-Dec;13(4):636-642. doi: 10.4103/aer.AER_126_19. Epub 2019 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'In patients with pituitary adenoma scheduled for endoscopic transsphenoidal pituitary surgery, it was aimed to compare the efficacy of postoperative pain relief of a selective α-2 agonist "Dexmedetomidine" and the rapid and short-acting opioid "Remifentanil" using the "Numerical Rating Scale" (NRS) administered alongside propofol in perioperative maintenance anesthesia. .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing transsphenoidal pituitary surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old\n* ASA-1 and ASA-2 patients\n\nExclusion Criteria:\n\n* Patients in need of postoperative intensive care'}, 'identificationModule': {'nctId': 'NCT05772832', 'briefTitle': 'COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'COMPARISON OF DEXMEDETOMIDINE AND REMIFENTANIL FOR POSTOPERATIVE PAIN IN TRANSPHENOIDAL Pituitary SURGERY', 'orgStudyIdInfo': {'id': 'KocaeliUI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GROUP USING REMIFENTANYL', 'description': 'THE GROUP USING PEROPERATIVE REMIFENTANYL AND PROPOFOL IN TRANSSPHENOIDAL Pituitary Surgery 0.01-0.2 μg /kg /min Remifentanyl and 3-12 mg/kg/h propofol', 'interventionNames': ['Drug: Remifentanyl']}, {'label': 'GROUP USING DEXMEDETOMIDINE', 'description': 'THE GROUP USING PEROPERATIVE DEXMEDETOMIDINE AND PROPOFOL IN TRANSSPHENOIDAL Pituitary Surgery 0.01-0.02 μg/kg/min (\\~0.5 μg/kg/h) continuous infusion of dexmedetomidine 1 mcg/kg 10 minutes after a loading dose and 3-12 mg/kg/h propofol', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Efficacy of dexmedetomidine on postoperative pain in patients undergoing transsphenoidal pituitary surgery', 'armGroupLabels': ['GROUP USING DEXMEDETOMIDINE']}, {'name': 'Remifentanyl', 'type': 'DRUG', 'description': 'Efficacy of remifentanyl on postoperative pain in patients undergoing transsphenoidal pituitary surgery', 'armGroupLabels': ['GROUP USING REMIFENTANYL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'state': 'IZMIT', 'country': 'Turkey (Türkiye)', 'facility': 'University of Kocaeli', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'İpek İZGİN AVCI', 'investigatorAffiliation': 'Kocaeli University'}}}}