Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure
NCT ID: NCT05582213
Last Updated: 2023-03-27
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
NA
40 participants
INTERVENTIONAL
2022-10-01
2023-02-10
Brief Summary
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Detailed Description
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Ketamine is often used for procedural sedation or as adjunct agent for general anesthesia in pediatrics with congenital heart disease. Ketamine is a chemical derivative of phencyclidine acting as a selective antagonist of the N-methyl-d-aspartate (NMDA) receptor, an ionotropic glutamate receptor that participates in analgesia, amnesia, and sedation pathways.
Ketamine has minimal impact on hemodynamics in children with congenital heart disease when used at usual clinical doses. Systemic vascular resistance and pulmonary vascular resistance are not significantly altered.
Sevoflurane is a sweet-smelling, highly fluorinated methyl isopropyl ether used as an inhalational anesthetic for induction and maintenance of general anesthesia. It proved to be safe as induction agent in noncardiac surgery and cardiac surgery. Sevoflurane has low solubility in blood, produces less arrhythmias and decrease in contractility less than halothane without changing pulmonary to systemic blood flow ratio in pediatrics with congenital heart disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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classic group (CL group)
20 patients will be enrolled to induction with sevofloran as inhalational anesthetics
induction of anesthesia
This group includes (20) patients will receive induction by sevoflurane 3% using open circuit (modified Ayre's T-piece) till loss of consciousness and will be maintained on oxygen mask on the same concentration of sevoflurane and connected to capnogram
Group ketamine:
This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness
induction of anesthesia
This group includes (20) patients will receive induction by sevoflurane 3% using open circuit (modified Ayre's T-piece) till loss of consciousness and will be maintained on oxygen mask on the same concentration of sevoflurane and connected to capnogram
Interventions
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induction of anesthesia
This group includes (20) patients will receive induction by sevoflurane 3% using open circuit (modified Ayre's T-piece) till loss of consciousness and will be maintained on oxygen mask on the same concentration of sevoflurane and connected to capnogram
Eligibility Criteria
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Inclusion Criteria
2. Both gender
3. Isolated congenital pulmonary stenosis
Exclusion Criteria
2. Previous open-heart surgery.
3. Other non-cardiac congenital anomalies
4. Refusal of parents
1 Month
1 Year
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Amr Gaber
lecturer clinical doctor
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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References
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Hoetama E, Prakoso R, Roebiono PS, Sakidjan I, Kurniawati Y, Siagian SN, Lelya O, Rahajoe AU, Harimurti GM, Lilyasari O. Balloon pulmonary valvuloplasty in neonates with critical pulmonary stenosis: Jugular or femoral. Ann Pediatr Cardiol. 2020 Jan-Mar;13(1):11-15. doi: 10.4103/apc.APC_14_19. Epub 2019 Nov 7.
Loomba RS, Gray SB, Flores S. Hemodynamic effects of ketamine in children with congenital heart disease and/or pulmonary hypertension. Congenit Heart Dis. 2018 Sep;13(5):646-654. doi: 10.1111/chd.12662. Epub 2018 Sep 27.
Sungur Ulke Z, Kartal U, Orhan Sungur M, Camci E, Tugrul M. Comparison of sevoflurane and ketamine for anesthetic induction in children with congenital heart disease. Paediatr Anaesth. 2008 Aug;18(8):715-21. doi: 10.1111/j.1460-9592.2008.02637.x.
de Waard-van der Spek FB, van den Berg GM, Oranje AP. EMLA cream: an improved local anesthetic. Review of current literature. Pediatr Dermatol. 1992 Jun;9(2):126-31. doi: 10.1111/j.1525-1470.1992.tb01228.x. No abstract available.
Herregods L, Mortier E, Donadoni R, Rolly G. A comparison of midazolam and diazepam for sedation during locoregional anesthesia. Acta Anaesthesiol Belg. 1987;38(1):97-102.
Berkenbosch JW, Wankum PC, Tobias JD. Prospective evaluation of dexmedetomidine for noninvasive procedural sedation in children. Pediatr Crit Care Med. 2005 Jul;6(4):435-9; quiz 440. doi: 10.1097/01.PCC.0000163680.50087.93.
Furyk JS, Meek RA, Egerton-Warburton D. Drugs for the treatment of nausea and vomiting in adults in the emergency department setting. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD010106. doi: 10.1002/14651858.CD010106.pub2.
8. Eric Scholar, in xPharm: The Comprehensive Pharmacology Reference, 2007
Williams GD, Philip BM, Chu LF, Boltz MG, Kamra K, Terwey H, Hammer GB, Perry SB, Feinstein JA, Ramamoorthy C. Ketamine does not increase pulmonary vascular resistance in children with pulmonary hypertension undergoing sevoflurane anesthesia and spontaneous ventilation. Anesth Analg. 2007 Dec;105(6):1578-84, table of contents. doi: 10.1213/01.ane.0000287656.29064.89.
Meyers RS. Pediatric fluid and electrolyte therapy. J Pediatr Pharmacol Ther. 2009 Oct;14(4):204-11. doi: 10.5863/1551-6776-14.4.204.
11. Rajan S, Tosh P, Sudevan M, Rahman AA, Kumar L. Anaesthetic management of a child with tetralogy of Fallot for dental extraction: a modified technique. Research and Opinion in Anesthesia and Intensive Care. 2019 Oct 1;6(4):470.
Russell IA, Miller Hance WC, Gregory G, Balea MC, Cassorla L, DeSilva A, Hickey RF, Reynolds LM, Rouine-Rapp K, Hanley FL, Reddy VM, Cahalan MK. The safety and efficacy of sevoflurane anesthesia in infants and children with congenital heart disease. Anesth Analg. 2001 May;92(5):1152-8. doi: 10.1097/00000539-200105000-00014.
Other Identifiers
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congenital pulmonary stenosis
Identifier Type: -
Identifier Source: org_study_id
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