## Protocol Section
### Identification Module
**NCT ID:** NCT05574179

**Brief Title:** Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA

**Official Title:** Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA in Pediatric Population Undergoing Inguinal Hernia Repair, Randomized Controlled Trial

#### Organization Study ID Info
**ID:** Sheikh Zayed Medical College
#### Organization
**Class:** OTHER_GOV
**Full Name:** Sheikh Zayed Medical College
### Status Module
#### Completion Date
**Date:** 2023-10-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-10-10

**Type:** ACTUAL

**Last Update Submit Date:** 2022-10-06

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2023-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-10

#### Study First Post Date
**Date:** 2022-10-10
**Type:** ACTUAL
**Study First Submit Date:** 2022-10-06
**Study First Submit QC Date:** 2022-10-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Sheikh Zayed Medical College

#### Responsible Party

**Investigator Affiliation:** Sheikh Zayed Medical College

**Investigator Full Name:** Barzah Durrani

**Investigator Title:** Dr Barzah durrani

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Comparison of sedative effects of dexmedetomidine and midazolam using ramsay sedation scores intraoperatively in children undergoing inguinal hernia repair.

**Detailed Description:** a randomized controlled trial to compare the sesative effects of dexmedetomidine and midazolam in pediatric population planned for inguinal herna repair under TIVA in sheikh zayed hospital rahim yar khan.

### Conditions Module

**Conditions:**

- Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Inj.midazolam

**Intervention Names:**

- Drug: Midazolam

**Label:** midazola.

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** inj.dexmedetomidine

**Intervention Names:**

- Drug: Dexmedetomidine injection

**Label:** Dexnedetomidine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dexnedetomidine

**Description:** Inj precedex 200mcg in 1ml given in stat doses

**Name:** Dexmedetomidine injection

**Other Names:**

- Precidex

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- midazola.

**Description:** Inj.midazolam 5mg/5ml given in stat doses

**Name:** Midazolam

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Dexmedetomidine is better sedative agent than midazolam in pediatric population

**Time Frame:** 25 minutes

#### Secondary Outcomes

**Measure:** Midazolam is better sedating agent than dexmedetomidine in pediatric population

**Time Frame:** 25 minutes

**Measure:** Midazolam and dexmedetomidine are equally good sedating agents in pediatric population

**Time Frame:** 25 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA I and II Age 6 to 12 years Any gender

Exclusion Criteria:

* ASA III and above Age less than 2 years and above 12 years Congenital heart disease Cardiac arrythmias Congenital abnormalities Respiratory disease Endocrine disorders Mental retardation Organ dysfunction Bleeding disorders Physician or family refusal Previous surgeries Allergy to any drug

**Healthy Volunteers:** True

**Maximum Age:** 12 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** From synopsis approval till completion of sample size

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9625

- Name: Hernia

- Relevance: LOW

- As Found: Unknown

- ID: M9630

- Name: Hernia, Inguinal

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000018757

- Term: GABA Modulators

- ID: D000018682

- Term: GABA Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Twice daily

- ID: M11845

- Name: Midazolam

- Relevance: HIGH

- As Found: Induction

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M20827

- Name: GABA Modulators

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008874

- Term: Midazolam

- ID: D000020927

- Term: Dexmedetomidine

### Misc Info Module

- Version Holder: 2024-05-24
