Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.
NCT ID: NCT02181543
Last Updated: 2017-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2013-08-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Clonidine
Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative.
Clonidine
1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.
No Clonidine
Usual care of Instituto de Medicina Integral Prof. Fernando Figueira.
No interventions assigned to this group
Interventions
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Clonidine
1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.
Eligibility Criteria
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Inclusion Criteria
* Need for tonsillectomy / adenotonsillectomy.
* Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
* Anestesia geral com sevoflurano.
* Use of Intraoperative dipyrone, 30-50mg/Kg, IV.
Exclusion Criteria
* Neurological Deficit.
* Use of another drug as medication before anesthesia.
2 Years
12 Years
ALL
No
Sponsors
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Professor Fernando Figueira Integral Medicine Institute
OTHER
Responsible Party
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Alex Sandro Rolland de Souza
Professor
Principal Investigators
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Alex SR Souza, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Fernando A Souza Júnior, MD
Role: STUDY_CHAIR
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Tania CM Couceiro, MD
Role: STUDY_CHAIR
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Ítalo GM Santos, Student
Role: STUDY_CHAIR
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Luciana C Lima, PhD
Role: STUDY_DIRECTOR
Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Locations
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Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Recife, Pernambuco, Brazil
Countries
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References
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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.
Silva LM, Braz LG, Modolo NS. Emergence agitation in pediatric anesthesia: current features. J Pediatr (Rio J). 2008 Mar-Apr;84(2):107-13. doi: 10.2223/JPED.1763.
Kulka PJ, Bressem M, Tryba M. Clonidine prevents sevoflurane-induced agitation in children. Anesth Analg. 2001 Aug;93(2):335-8, 2nd contents page.
Malviya S, Voepel-Lewis T, Ramamurthi RJ, Burke C, Tait AR. Clonidine for the prevention of emergence agitation in young children: efficacy and recovery profile. Paediatr Anaesth. 2006 May;16(5):554-9. doi: 10.1111/j.1460-9592.2006.01818.x.
Fazi L, Jantzen EC, Rose JB, Kurth CD, Watcha MF. A comparison of oral clonidine and oral midazolam as preanesthetic medications in the pediatric tonsillectomy patient. Anesth Analg. 2001 Jan;92(1):56-61. doi: 10.1097/00000539-200101000-00011.
Tazeroualti N, De Groote F, De Hert S, De Ville A, Dierick A, Van der Linden P. Oral clonidine vs midazolam in the prevention of sevoflurane-induced agitation in children. a prospective, randomized, controlled trial. Br J Anaesth. 2007 May;98(5):667-71. doi: 10.1093/bja/aem071. Epub 2007 Apr 7.
Sousa-Junior FA, Souza ASR, Lima LC, Santos IGM, Menezes LAP, Ratis PAPL, Couceiro TCM. Intraoperative clonidine to prevent postoperative emergence delirium following sevoflurane anesthesia in pediatric patients: a randomized clinical trial. Braz J Anesthesiol. 2021 Jan-Feb;71(1):5-10. doi: 10.1016/j.bjane.2020.12.003. Epub 2020 Dec 25.
Related Links
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Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
Other Identifiers
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U1111-1157-8852
Identifier Type: -
Identifier Source: org_study_id