Clinical trial

Comparative Study of Preoperative Intravenous Dexmedetomidine Versus Preoperative Intravenous Midazolam On the Incidence of Emergency Delirium in Pediatric Patients Undergoing Tonsillictomy and Adenoidectomy a Prospective Randomized Clincal Trial

Name

Emergency delirium

Description

Primary outcom Compare the effectiveness of study drugs on reducing the incidence of emergence delirium . Secondary outcomes: Sedation score Intensity of pain by FLACC Extubation time Iength of stay in Post anesthetic care unite (PACU ) Incidence of negative post operative behavioural changes (NPOBCs ) Laryngeospasm ny adverse effects

Trial arms

Trial start

2024-01-01

Estimated PCD

2024-09-01

Trial end

2024-10-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Dexmedetomidine and Midazolam

This will be a prospective, double-blind, randomized controlled study conducted between October 2023and June 2024 . Patients aged( 2_12) years, American Society of Anesthesiologists class (ASA) I or II, scheduled for tonsillectomy with and without adenoidectomy will be randomized to receive intravenous dexmedetomidine 0.5 μg/kg Or intravenous midazolam 0.1 mg /kg(Group A) or (Group B) over 10 minutes after induction of anesthesia. The primary outcome is the incidence of ED within 30 minutes after extubation. Other outcomes are the incidence of pain, extubation time, post-anesthesia care unit (PACU) length of stay after extubation, adverse events, and the incidence of negative postoperative behavioral changes (NPOBCs).

Arms:

Dexemedetomidine group A, Midazolam group B

Size

100

Primary endpoint

Emergency Delirium

30 minutes

Eligibility criteria

Inclusion Criteria: - Pediatric patients aged 2-12 years With ASA physical status 1 or 2 Who were scheduled for tonsillectomy with and without adenoidectomy under general anesthesia Exclusion Criteria: * Emergency surgery Intellectual disability Neurological disease Renal , hepatic, cardiac or respiratory disease Allergy to the study drugs

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-01-22

1 organization

1 product

1 indication

Organization

Esraa Abdel Azez Soltan Mohamed Zayed

Product

Dexmedetomidine + Midazolam

Indication

Emergence Delirium