---
title: Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure
nct_id: NCT05582213
overall_status: COMPLETED
phase: NA
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: Congenital Pulmonary Stenosis
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05582213.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05582213"
ct_last_update_post_date: 2023-03-27
last_seen_at: "2026-05-12T06:54:46.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05582213](https://clinicaltrials.gov/study/NCT05582213)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Congenital Pulmonary Stenosis
- **Start Date:** 2022-10-01
- **Completion Date:** 2023-02-10
- **CT.gov Last Update:** 2023-03-27

## 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.

## Eligibility

- **Minimum age:** 1 Month
- **Maximum age:** 1 Year
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **classic group (CL group)** (OTHER) — 20 patients will be enrolled to induction with sevofloran as inhalational anesthetics
- **Group ketamine:** (OTHER) — This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness

## 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

## Primary Outcomes

- **right ventricular pressure** _(time frame: baseline)_ — right ventricular pressure before induction of anesthesia

## Secondary Outcomes

- **vital data** _(time frame: baseline)_

## Locations (1)

- Ain Shams University, Cairo, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ain shams university|cairo||egypt` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT05582213*  
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