Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-08 @ 10:19 AM
Study NCT ID:
NCT02711904
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2013-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concentrations of Remifentanil for Extubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-16', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough', 'timeFrame': 'It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated', 'description': 'Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated.\n\nCough Scale\n\n* Grade 0 = No cough\n* Grade 1 = Mild (only episode of cough)\n* Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds)\n* Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities).'}], 'secondaryOutcomes': [{'measure': 'Wake time.', 'timeFrame': 'During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.', 'description': 'When vaporizer where closed until the patient responds to the verbal stimulus and is extubated.\n\nDefined as the time taken to open eyes after having turned off the halogenated inhalation anesthetics.'}, {'measure': 'Ramsay scale at the time of extubation', 'timeFrame': 'During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered', 'description': 'Ramsay scale: score objective system for measuring drug-induced sedation\n\n* Score 1: Anxious or restless or both\n* Score 2: Cooperative, orientated and tranquil\n* Score 3: Responding to commands\n* Score 4: Brisk response to stimulus\n* Score 5: Sluggish response to stimulus\n* Score 6: No response to stimulus'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Extubation', 'Cough', 'Target Controlled Anesthesia (TACAN)'], 'conditions': ['Cough']}, 'referencesModule': {'references': [{'pmid': '8024135', 'type': 'BACKGROUND', 'citation': 'Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.'}, {'pmid': '16095449', 'type': 'BACKGROUND', 'citation': 'Guler G, Akin A, Tosun Z, Eskitascoglu E, Mizrak A, Boyaci A. Single-dose dexmedetomidine attenuates airway and circulatory reflexes during extubation. Acta Anaesthesiol Scand. 2005 Sep;49(8):1088-91. doi: 10.1111/j.1399-6576.2005.00780.x.'}, {'pmid': '16450594', 'type': 'BACKGROUND', 'citation': 'Saghaei M, Reisinejad A, Soltani H. Prophylactic versus therapeutic administration of intravenous lidocaine for suppression of post-extubation cough following cataract surgery: a randomized double blind placebo controlled clinical trial. Acta Anaesthesiol Taiwan. 2005 Dec;43(4):205-9.'}, {'pmid': '15385385', 'type': 'BACKGROUND', 'citation': 'Minogue SC, Ralph J, Lampa MJ. Laryngotracheal topicalization with lidocaine before intubation decreases the incidence of coughing on emergence from general anesthesia. Anesth Analg. 2004 Oct;99(4):1253-1257. doi: 10.1213/01.ANE.0000132779.27085.52.'}, {'pmid': '10866913', 'type': 'BACKGROUND', 'citation': 'Fagan C, Frizelle HP, Laffey J, Hannon V, Carey M. The effects of intracuff lidocaine on endotracheal-tube-induced emergence phenomena after general anesthesia. Anesth Analg. 2000 Jul;91(1):201-5. doi: 10.1097/00000539-200007000-00038.'}, {'pmid': '9637637', 'type': 'BACKGROUND', 'citation': 'Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.'}, {'pmid': '7725888', 'type': 'BACKGROUND', 'citation': 'Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.'}, {'pmid': '7598918', 'type': 'BACKGROUND', 'citation': 'Mendel P, Fredman B, White PF. Alfentanil suppresses coughing and agitation during emergence from isoflurane anesthesia. J Clin Anesth. 1995 Mar;7(2):114-8. doi: 10.1016/0952-8180(94)00024-x.'}, {'pmid': '11240151', 'type': 'BACKGROUND', 'citation': "Sant'Ambrogio G, Widdicombe J. Reflexes from airway rapidly adapting receptors. Respir Physiol. 2001 Mar;125(1-2):33-45. doi: 10.1016/s0034-5687(00)00203-6."}, {'pmid': '20422846', 'type': 'BACKGROUND', 'citation': 'Lema FE, Tafur LA, Giraldo C, Delgado MA. [Incidence of cough after desflurane and sevoflurane administration through a laryngeal mask: a controlled clinical trial]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):141-6. doi: 10.1016/s0034-9356(10)70188-2. Spanish.'}, {'pmid': '4835444', 'type': 'BACKGROUND', 'citation': 'Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.'}, {'pmid': '10073732', 'type': 'BACKGROUND', 'citation': 'Grahame-Smith DG. How will knowledge of the human genome affect drug therapy? Br J Clin Pharmacol. 1999 Jan;47(1):7-10. doi: 10.1046/j.1365-2125.1999.00909.x. No abstract available.'}, {'pmid': '15536889', 'type': 'BACKGROUND', 'citation': 'Van Poucke GE, Bravo LJ, Shafer SL. Target controlled infusions: targeting the effect site while limiting peak plasma concentration. IEEE Trans Biomed Eng. 2004 Nov;51(11):1869-75. doi: 10.1109/TBME.2004.827935.'}, {'type': 'BACKGROUND', 'citation': 'Tafur LA, Gómez JM, Parra LE. Validación de nomogramas de remifentanil y propofol para la administración de anestesia total endovenosa. Rev. Col. Anest. 2009; 37:21-8.'}, {'pmid': '12883407', 'type': 'BACKGROUND', 'citation': 'Mertens MJ, Olofsen E, Engbers FH, Burm AG, Bovill JG, Vuyk J. Propofol reduces perioperative remifentanil requirements in a synergistic manner: response surface modeling of perioperative remifentanil-propofol interactions. Anesthesiology. 2003 Aug;99(2):347-59. doi: 10.1097/00000542-200308000-00016.'}, {'pmid': '11574362', 'type': 'BACKGROUND', 'citation': 'Eger EI 2nd. Age, minimum alveolar anesthetic concentration, and minimum alveolar anesthetic concentration-awake. Anesth Analg. 2001 Oct;93(4):947-53. doi: 10.1097/00000539-200110000-00029.'}, {'pmid': '19168857', 'type': 'BACKGROUND', 'citation': 'Matsuura T, Oda Y, Tanaka K, Mori T, Nishikawa K, Asada A. Advance of age decreases the minimum alveolar concentrations of isoflurane and sevoflurane for maintaining bispectral index below 50. Br J Anaesth. 2009 Mar;102(3):331-5. doi: 10.1093/bja/aen382. Epub 2009 Jan 24.'}, {'pmid': '14739797', 'type': 'BACKGROUND', 'citation': 'Albertin A, Casati A, Bergonzi P, Fano G, Torri G. Effects of two target-controlled concentrations (1 and 3 ng/ml) of remifentanil on MAC(BAR) of sevoflurane. Anesthesiology. 2004 Feb;100(2):255-9. doi: 10.1097/00000542-200402000-00012.'}, {'pmid': '11873028', 'type': 'BACKGROUND', 'citation': 'Olofsen E, Sleigh JW, Dahan A. The influence of remifentanil on the dynamic relationship between sevoflurane and surrogate anesthetic effect measures derived from the EEG. Anesthesiology. 2002 Mar;96(3):555-64. doi: 10.1097/00000542-200203000-00009.'}, {'pmid': '16871060', 'type': 'BACKGROUND', 'citation': 'Manyam SC, Gupta DK, Johnson KB, White JL, Pace NL, Westenskow DR, Egan TD. Opioid-volatile anesthetic synergy: a response surface model with remifentanil and sevoflurane as prototypes. Anesthesiology. 2006 Aug;105(2):267-78. doi: 10.1097/00000542-200608000-00009.'}, {'type': 'BACKGROUND', 'citation': 'Dennis R. Cómo estimar el tamaño de la muestra en investigación con humanos. Acta Méd Colom. 1989;14: 92-99.'}, {'type': 'BACKGROUND', 'citation': 'Dobson AJ. Calculating simple size. Transactions of the Menzie Foundation. 1984; 7:75-79.'}, {'pmid': '15220181', 'type': 'BACKGROUND', 'citation': 'Lerou JG. Nomogram to estimate age-related MAC. Br J Anaesth. 2004 Aug;93(2):288-91. doi: 10.1093/bja/aeh186. Epub 2004 Jun 25.'}, {'type': 'BACKGROUND', 'citation': 'Coleridge HM, Coleridge JCC. Reflexes evoked from the tracheobronchial tree and lungs. In: Handbook of Physiology, Section 3: the Respiratory System, Vol II: Control of Breathing, Part I (Cherniack NS, Widdicombe JG, eds). Washington, DC:American Physiological Society, 1986;395-429.'}, {'type': 'BACKGROUND', 'citation': 'Widdicombe JG. Vagal reflexes in the airways. In: Neural Regulation of the Airways in Health and Disease (Kaliner M, Barnes PJ, eds). New York:Marcel Dekker, 1988;187-202.'}, {'pmid': '21738845', 'type': 'BACKGROUND', 'citation': 'Lee DH, Park SJ. Effects of 10% lidocaine spray on arterial pressure increase due to suspension laryngoscopy and cough during extubation. Korean J Anesthesiol. 2011 Jun;60(6):422-7. doi: 10.4097/kjae.2011.60.6.422. Epub 2011 Jun 17.'}, {'pmid': '16428692', 'type': 'BACKGROUND', 'citation': 'Irwin RS. Complications of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):54S-58S. doi: 10.1378/chest.129.1_suppl.54S.'}, {'pmid': '4451611', 'type': 'BACKGROUND', 'citation': 'Leech P, Barker J, Fitch W. Proceedings: Changes in intracranial pressure and systemic arterial pressure during the termination of anaesthesia. Br J Anaesth. 1974 Apr;46(4):315-6. doi: 10.1093/bja/46.4.315-a. No abstract available.'}, {'pmid': '19411668', 'type': 'BACKGROUND', 'citation': 'Lee B, Lee JR, Na S. Targeting smooth emergence: the effect site concentration of remifentanil for preventing cough during emergence during propofol-remifentanil anaesthesia for thyroid surgery. Br J Anaesth. 2009 Jun;102(6):775-8. doi: 10.1093/bja/aep090. Epub 2009 May 2.'}, {'pmid': '17660457', 'type': 'BACKGROUND', 'citation': 'Hohlrieder M, Tiefenthaler W, Klaus H, Gabl M, Kavakebi P, Keller C, Benzer A. Effect of total intravenous anaesthesia and balanced anaesthesia on the frequency of coughing during emergence from the anaesthesia. Br J Anaesth. 2007 Oct;99(4):587-91. doi: 10.1093/bja/aem203. Epub 2007 Jul 27.'}, {'pmid': '10673886', 'type': 'BACKGROUND', 'citation': 'Shajar MA, Thompson JP, Hall AP, Leslie NA, Fox AJ. Effect of a remifentanil bolus dose on the cardiovascular response to emergence from anaesthesia and tracheal extubation. Br J Anaesth. 1999 Oct;83(4):654-6. doi: 10.1093/bja/83.4.654.'}, {'pmid': '11575408', 'type': 'BACKGROUND', 'citation': 'Wilhelm W, Schlaich N, Harrer J, Kleinschmidt S, Muller M, Larsen R. Recovery and neurological examination after remifentanil-desflurane or fentanyl-desflurane anaesthesia for carotid artery surgery. Br J Anaesth. 2001 Jan;86(1):44-9. doi: 10.1093/bja/86.1.44.'}, {'pmid': '20645945', 'type': 'BACKGROUND', 'citation': 'Jun NH, Lee JW, Song JW, Koh JC, Park WS, Shim YH. Optimal effect-site concentration of remifentanil for preventing cough during emergence from sevoflurane-remifentanil anaesthesia. Anaesthesia. 2010 Sep;65(9):930-5. doi: 10.1111/j.1365-2044.2010.06450.x.'}]}, 'descriptionModule': {'briefSummary': 'Condition of the State: (terminated, recruiting, etc.) Terminated\n\nStudy Design: Main Objective:\n\nCompare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia', 'detailedDescription': 'Phase of the study:\n\nPhase IV\n\nIntervention:\n\nDrug: U Extubation\n\nOther Names:\n\nConcentration 2 - 3 ng/ml Dose of remifentanil according to the randomization: Letter U between 2 - 3 ng/ml. The infusions that were used to reach the (PC) target were: Group U = 2 - 3 ng/ml. 20 years old - 6.0 mcg/Kg/h, 30 years old - 5.7 mcg/Kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h.\n\nDrug: Extubation T\n\nOther Names:\n\nConcentration 3 - 4 ng/ml Dose of infusion of remifentanil to reach a (PC) 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: Group T = 3 - 4 ng/ml. 20 years old - 9.0 mcg/Kg/h, 30 years old - 8.5 mcg/Kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h.\n\nNumber of arms:\n\n2\n\nMasking:\n\nThe patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis.\n\nTo guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. Ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (U) o (T). The evaluation of the cough, its intensity and the Ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion.\n\nAllocation:\n\nTwo were allocated for the use: Concentration of remifentanil of 2 - 3 ng/ml (group U) and concentration of remifentanil of 3 - 4 ng/ml (group T).\n\nRecruitment:\n\nA patient was recruited between the period of January 2011 and July 2012.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 18-70 years\n* Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II\n* Undergoing elective ear surgery\n\nExclusion Criteria:\n\n* Patients who are contraindicated remifentanil\n* Patients undergoing emergency surgery\n* Pulmonary Pathology (ASTHMA - COPD)\n* Index of body mass greater than 35\n* Background of respiratory failure three weeks prior to the procedure\n* Smokers'}, 'identificationModule': {'nctId': 'NCT02711904', 'acronym': 'REMEX', 'briefTitle': 'Concentrations of Remifentanil for Extubation', 'organization': {'class': 'OTHER', 'fullName': 'Seganest'}, 'officialTitle': 'Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'SEGANEST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extubation U', 'description': 'Remifentanil concentration between 2 - 3 ng/ml.', 'interventionNames': ['Drug: Extubation U']}, {'type': 'EXPERIMENTAL', 'label': 'Extubation T', 'description': 'Remifentanil concentration between 3 - 4 ng/ml', 'interventionNames': ['Drug: Extubation T']}], 'interventions': [{'name': 'Extubation U', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were:\n\n* 20 years old - 6.0 mcg/Kg/h\n* 30 years old - 5.7 mcg/Kg/h\n* 40 years old - 5.3 mcg/kg/h\n* 50 years old - 5.0 mcg/kg/h\n* 60 years old - 4.6 mcg/kg/h\n* 70 years old - 4.3 mcg/kg/h\n* 80 years old - 4.0 mcg kg/h.', 'armGroupLabels': ['Extubation U']}, {'name': 'Extubation T', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Dose of infusion of remifentanil to reach a PC 3 - 4 ng/ml, in the following manner:\n\nThe assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient.\n\nThe remifentanil dose was adjusted according to the randomization:\n\n* 20 years old - 9.0 mcg/Kg/h\n* 30 years old - 8.5 mcg/Kg/h\n* 40 years old - 8.0 mcg/kg/h\n* 50 years old - 7.5 mcg/kg/h\n* 60 years old - 7.0 mcg/kg/h\n* 70 years old - 6.5 mcg/kg/h\n* 80 years old - 6.0 mcg kg/h.', 'armGroupLabels': ['Extubation T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '288 00', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Instituto Para Niños Ciegos y Sordos del Valle del Cauca', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}], 'overallOfficials': [{'name': 'LUIS A TAFUR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seganest'}, {'name': 'Eduardo Lema, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seganest'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual data of the participants (IPD) were only available to the ethics committee of the institution.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seganest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto Para Ninos Ciegos y Sordos del Valle del Cauca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LUIS ALBERTO TAFUR B', 'investigatorAffiliation': 'Seganest'}}}}