Comparison of Sedative Effect of Dexmedetomidine and Midazolam for TIVA

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Choosing Better Drug Option for Sedation in Pediatric Population Intraoperatively
• Intervention / Treatment: Drug: Midazolam; Drug: Dexmedetomidine injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: midazola.; Inj.midazolam	Drug: Midazolam; Inj.midazolam 5mg/5ml given in stat doses
Experimental: Dexnedetomidine; inj.dexmedetomidine	Drug: Dexmedetomidine injection; Inj precedex 200mcg in 1ml given in stat doses; Other Names: Precidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dexmedetomidine is better sedative agent than midazolam in pediatric population	25 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Midazolam is better sedating agent than dexmedetomidine in pediatric population	25 minutes
Midazolam and dexmedetomidine are equally good sedating agents in pediatric population	25 minutes

Collaborators and Investigators

• Sponsor: Sheikh Zayed Medical College

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Sheikh Zayed Medical College

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: From synopsis approval till completion of sample size
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No