Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure

NCT05582213 | Completed

• 1 other identifier: congenital pulmonary stenosis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effect of different anesthetic drugs used for induction of anesthesia ketamine versus sevoflurane on the RV pressure in pediatrics undergoing balloon dilatation for congenital pulmonary stenosis.

Conditions

Congenital Pulmonary Stenosis

Outcome Measures

Primary Outcomes (1)

• right ventricular pressure

  right ventricular pressure before induction of anesthesia

  baseline

Secondary Outcomes (1)

• vital data

  baseline

Study Arms (2)

classic group (CL group)

OTHER

20 patients will be enrolled to induction with sevofloran as inhalational anesthetics

Diagnostic Test: induction of anesthesia

Group ketamine:

OTHER

This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness

Diagnostic Test: induction of anesthesia

Interventions

induction of anesthesia DIAGNOSTIC_TEST

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:; classic group (CL group)

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age from 1 month to 1 year.
• Both gender
• Isolated congenital pulmonary stenosis

You may not qualify if:

• Multiple cardiac congenital anomalies.
• Previous open-heart surgery.
• Other non-cardiac congenital anomalies
• Refusal of parents

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (12)

• 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.

  PMID: 32030030 BACKGROUND

• 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.

  PMID: 30259660 BACKGROUND

• 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.

  PMID: 18544145 BACKGROUND

• 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.

  PMID: 1603740 BACKGROUND

• 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.

  PMID: 3591272 BACKGROUND

• 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.

  PMID: 15982430 BACKGROUND

• 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.

  PMID: 26411330 BACKGROUND

• 8. Eric Scholar, in xPharm: The Comprehensive Pharmacology Reference, 2007

  BACKGROUND

• 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.

  PMID: 18042853 BACKGROUND

• 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.

  PMID: 23055905 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11323338 BACKGROUND

MeSH Terms

Conditions

Stenosis, Pulmonary Artery

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer clinical doctor

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: October 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 10, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

EG (1)