## Protocol Section
### Identification Module
**NCT ID:** NCT06431178

**Brief Title:** General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

**Official Title:** A Comparative Study Between General Anesthesia Versus Sedation By Dexmedetomidine and Ketamine With Local Infiltration for Percutaneous Transcatheter Closure of Atrial Septal Defect in Pediatric Patients

#### Organization Study ID Info
**ID:** 36264MD57/3/23
#### Organization
**Class:** OTHER
**Full Name:** Tanta University
### Status Module
#### Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tanta University

#### Responsible Party

**Investigator Affiliation:** Tanta University

**Investigator Full Name:** Aya Ebrahim Abdelhafez Mashal

**Investigator Title:** Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The aim of the present study is to compare between general anesthesia versus sedation with dexmedetomidine and ketamine with local infilteration at the catheter insertion site in pediatric patients undergoing transcutaneous closure of atrial septal defect on hemodynamic changes.

**Detailed Description:** Atrial septal defect (ASD) is one of the most common types of congenital heart defects, occurring in about 25% of children General anaesthesia is usually obtained with tracheal intubation and mechanical ventilation or spontaneous breathing, the depth of anesthesia required to tolerate the presence of a tracheal tube will invariably lead to some reduction in myocardial contractility and alteration of respiratory mechanics. The goal of anesthetic technique is to provide sedation and analgesia during cardiac catheterization to ensure immobility and hemodynamic stability.

Ketamine is an N-methyl-D-aspartate receptor (NMDA) antagonist with sedative, analgesic, and sympathomimetic effects. Among its benefits ,it has the ability to protect airway reflexes with minimal effect on ventilatory drive.

Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonist with sedative, anxiolytic, and analgesic effect, it also blunts the sympathetic nervous system response to surgical stimulation.

### Conditions Module

**Conditions:**

- General Anesthesia

- Dexmedetomidine

- Ketamine

- Local Infiltration

- Atrial Septal Defect

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation.

Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence.

**Intervention Names:**

- Other: General Anesthesia

**Label:** General anesthesia

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable

**Intervention Names:**

- Other: Local anesthesia

**Label:** Local anesthesia

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- General anesthesia

**Description:** General anesthesia will be induced by 6% sevoflurane with a face mask. An intravenous line(22-g cannula )will be inserted then fentanyl 1mcg-kg will be given . Endotracheal tube will be used to intubate the patient .Anesthesia will be maintained by 2%sevoflurane inhalation in an oxygen air compination 1:1 throught the operation . Crystalloid solution was used to replenish fluid according "4/2/1-rule". Monitoring during the procedure include , ejection fraction (EF),blood pressure, heart rate, respiratory rate, and O2 saturation are measured at baseline, after induction, 10 min after catheter insertion,30 min during procedure and post emergence.

**Name:** General Anesthesia

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Local anesthesia

**Description:** A nasal cannula was placed and oxygen delivered at 2 to 3 L/minute. An intravenous line will be inserted (22-g cannula). The sedation regimen will include loading dose of dexmedetomidine (1 mcg/kg) and ketamine (1mg/kg) over 10 minutes . The patient will receive an infusion of dexmedetomidine at 0.7 mcg/kg per hour and ketamine 0.5 mg/kg/hr as maintenance sedation .Local infilteration of xylocaine 2% at dose 2mg/kg will be given for vascular access in cardiac catheterization . After completion of the procedure the infusion pump will be stopped to ensure that the patient is fully awake and vitally stable

**Name:** Local anesthesia

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Heart rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

**Measure:** Heart rate

**Time Frame:** Immediately after the intervention

#### Secondary Outcomes

**Description:** Mean arterial blood pressure will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

**Measure:** Mean arterial blood pressure

**Time Frame:** Immediately after the intervention

**Description:** O2 saturation will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

**Measure:** O2 saturation

**Time Frame:** Immediately after the intervention

**Description:** Respiratory rate will be measured at baseline, after induction ,10 min after catheter insertion site,30 min during procedure and post emergence in both groups.

**Measure:** Respiratory rate

**Time Frame:** Immediately after the intervention

**Description:** Length of hospital stay will be measured from admission till discharge from hospital

**Measure:** Lengh of hospital stay

**Time Frame:** 28 days postoperative

**Description:** Recovery time will be measured from the end of surgery till discharge from post-anesthesia care unit (PACU).

**Measure:** Recovery time

**Time Frame:** Immediately after discharge from post-anesthesia care unit

**Description:** Postoperative complications such as arrythmia, hypotension, bradycardia, nausea and vomiting will be measured.

**Measure:** Complications

**Time Frame:** 24 hours postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 3-8 years old.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status II-III
* Pediatric patients scheduled for elective transcatheter atrial septal defect closure.

Exclusion Criteria:

* Patients with multiple congenital anomalies.
* Patients with congestive heart failure
* Patients with Organ dysfunction liver or renal disease or pulmonary disease.
* Recent chest infection.
* Airway abnormalities.

**Maximum Age:** 8 Years

**Minimum Age:** 3 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ayaebrahim406@gmail.com

**Name:** Aya E Mashal, Master

**Phone:** 00201009167298

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tanta

**Contacts:**

***Contact 1:***

- **Email:** ayaebrahim406@gmail.com

- **Name:** Aya E Mashal, Master

- **Phone:** 00201009167298

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mohammad E Okab, MD

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Aymen A Abd Elmaksoud Yousef, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Jehan M Darwish, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Egypt

**Facility:** Aya Ebrahim Abdelhafez Mashal

**State:** El-Gharbia Governorate, Egypt

**Status:** RECRUITING

**Zip:** 31527

### IPD Sharing Statement Module

**Access Criteria:** The data will be available upon a reasonable request from the corresponding author

**Description:** The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** After the end of study for one year.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006330

- Term: Heart Defects, Congenital

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9431

- Name: Heart Septal Defects

- Relevance: HIGH

- As Found: Septal Defect

- ID: M9432

- Name: Heart Septal Defects, Atrial

- Relevance: HIGH

- As Found: Atrial Septal Defect

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006343

- Term: Heart Septal Defects

- ID: D000006344

- Term: Heart Septal Defects, Atrial

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: PlAggInh

- Name: Platelet Aggregation Inhibitors

### Intervention Browse Module - Browse Leaves

- ID: M8418

- Name: Fentanyl

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

- ID: M22662

- Name: Dexmedetomidine

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M10674

- Name: Ketamine

- Relevance: LOW

- As Found: Unknown

- ID: M1673

- Name: Sevoflurane

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-31
