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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congenital Pulmonary Stenosis

Eligibility Criteria

1 Month - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Multiple cardiac congenital anomalies.
  2. Previous open-heart surgery.
  3. Other non-cardiac congenital anomalies
  4. 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

First Posted
October 10, 2022
Last Updated
March 23, 2023
Sponsor
Ain Shams University
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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
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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
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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
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PubMed Identifier
1603740
Citation
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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.
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PubMed Identifier
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Citation
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PubMed Identifier
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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.
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure

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