Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure
Primary Purpose
Congenital Pulmonary Stenosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
induction of anesthesia
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Pulmonary Stenosis
Eligibility Criteria
Inclusion Criteria:
- Age from 1 month to 1 year.
- Both gender
- Isolated congenital pulmonary stenosis
Exclusion Criteria:
- Multiple cardiac congenital anomalies.
- Previous open-heart surgery.
- Other non-cardiac congenital anomalies
- Refusal of parents
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
classic group (CL group)
Group ketamine:
Arm Description
20 patients will be enrolled to induction with sevofloran as inhalational anesthetics
This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness
Outcomes
Primary Outcome Measures
right ventricular pressure
right ventricular pressure before induction of anesthesia
Secondary Outcome Measures
vital data
Spo2 in both group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05582213
Brief Title
Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure
Official Title
Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure During Congenital Pulmonary Stenosis Balloon Dilatation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which manifest during the neonatal period with cyanosis. Surgical valvotomy was the procedure of choice for critical PS; however, balloon pulmonary valvoplasty (BPV) has now become the standard management.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Pulmonary Stenosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
classic group (CL group)
Arm Type
Other
Arm Description
20 patients will be enrolled to induction with sevofloran as inhalational anesthetics
Arm Title
Group ketamine:
Arm Type
Other
Arm Description
This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness
Intervention Type
Diagnostic Test
Intervention Name(s)
induction of anesthesia
Intervention Description
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
Primary Outcome Measure Information:
Title
right ventricular pressure
Description
right ventricular pressure before induction of anesthesia
Time Frame
baseline
Secondary Outcome Measure Information:
Title
vital data
Description
Spo2 in both group
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 1 month to 1 year.
Both gender
Isolated congenital pulmonary stenosis
Exclusion Criteria:
Multiple cardiac congenital anomalies.
Previous open-heart surgery.
Other non-cardiac congenital anomalies
Refusal of parents
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
32030030
Citation
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.
Results Reference
background
PubMed Identifier
30259660
Citation
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.
Results Reference
background
PubMed Identifier
18544145
Citation
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.
Results Reference
background
PubMed Identifier
1603740
Citation
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.
Results Reference
background
PubMed Identifier
3591272
Citation
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.
Results Reference
background
PubMed Identifier
15982430
Citation
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.
Results Reference
background
PubMed Identifier
26411330
Citation
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.
Results Reference
background
Citation
8. Eric Scholar, in xPharm: The Comprehensive Pharmacology Reference, 2007
Results Reference
background
PubMed Identifier
18042853
Citation
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.
Results Reference
background
PubMed Identifier
23055905
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
11323338
Citation
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.
Results Reference
background
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Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure
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