Emergence Agitation of Sevoflurane in Pediatric

NCT06830564 | Completed Phase 2 DMC

• 1 other identifier: FMASU MS127/2024
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Low dose nalbuphine versus dexmedetomidine on prevention of emergence agitation in children

Conditions

Emergence Delirium

Keywords

Emergence delirium

Outcome Measures

Primary Outcomes (1)

• incidence of emergence agitation after sevoflurane anaesthesia

  The aim of this study is to prevent 80% of emergence agitation of pediatric undergoing ENT surgeries using sevoflurane as inhalational anaesthesia . low dose nalbuphine versus dexmedetomidine

  6 months

Study Arms (2)

Nalbuphine group

ACTIVE COMPARATOR

We will give the patient before extubation by15 minute nalbuphine with dose 0.1 mg /kg and we will assess the emergence agitation by delirium score every 15 minutes for half an hour

Drug: we will give the patient 0.1 mg nalbuphine 15 min before the end of the procedure

Dexmedetomidine group

ACTIVE COMPARATOR

We will give the patient before extubation by 15 minute nalbuphine with dose 0.5 mic /kg and we will assess the emergence agitation by delirium score every 15 minutes for half an hour

Drug: we will give the patient 0.5 mg dexmedetomidine 15 min before the end of the procedure

Interventions

we will give the patient 0.1 mg nalbuphine 15 min before the end of the procedure DRUG

The study medications will be prepared by the local pharmacy as 10 ml syringes of nalbuphine IV that will be handled to the anesthesiologist in charge in OR room who will be blinded to the nature of the medications used, and study medications will be given 15 minutes before the end of surgical procedure and it will be given slowly for five minutes. . After extubation, patients will be taken to postanesthetic care unit . on arrival vital data will be measured. The anesthesiologist following up the patient will be blinded to the groups. The time of extubation will be defined as zero and after 15 minutes will be defined as one . Assessment of agitation will be done at time zero and time 1 and every fifteen minutes for 30 minutes using paediatric anaesthesia Emergence delirium scale (PAEDS)

Nalbuphine group

we will give the patient 0.5 mg dexmedetomidine 15 min before the end of the procedure DRUG

The study medications will be prepared by the local pharmacy as 10 ml syringes of dexmedetomidine IV that will be handled to the anesthesiologist in charge in OR room who will be blinded to the nature of the medications used, and study medications will be given 15 minutes before the end of surgical procedure and it will be given slowly for five minutes. . After extubation, patients will be taken to postanesthetic care unit . on arrival vital data will be measured. The anesthesiologist following up the patient will be blinded to the groups. The time of extubation will be defined as zero and after 15 minutes will be defined as one . Assessment of agitation will be done at time zero and time 1 and every fifteen minutes for 30 minutes using pediatric anesthesia Emergence delirium scale (PAEDS) .

Dexmedetomidine group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 - 10 years.
• Sex: male and female
• Patients with ASA classification I and II

You may not qualify if:

• Refusal of the caregiver to give written informed consent.
• History of allergy to the medications used in the study.
• psychiatric disorder.
• ASA classification III - IV.
• Fever, cough, asthma or upper respiratory tract infection.
• surgery more than 2 hours
• Hearing defect that limits communication.
• Neurological disorder .
• History of malignant hyperthermia.
• surgeries more than 2 hours.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Nalbuphine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Madlin A selwanes, M.B.B.CH

  anesthesia resident at Ain shames university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: prospective, randomized, double-blinded, comparative study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: paediatric patients undergoing ENT surgeries will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes: 1. Group A will receive dexmedetomidine IV 0.5 μg/kg. 2. Group B will receive nalbuphine IV 0 .1 mg /kg.

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: February 17, 2025
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 6/2025
• Access Criteria: Free

Locations

EG (1)