Emergence Agitation of Sevoflurane in Pediatric

The Effect of the Low Dose Nalbuphine Versus Dexmedetomidine on the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Children Undergoing ENT Surgeries

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

Study Overview

• Status: Completed
• Conditions: Emergence Delirium
• Intervention / Treatment: Drug: we will give the patient 0.1 mg nalbuphine 15 min before the end of the procedure; Drug: we will give the patient 0.5 mg dexmedetomidine 15 min before the end of the procedure

Detailed Description

The incidence of emergence agitation (EA) varies between 18% and 80.

EA occurs most frequently in preschool children during the early stage of emergence from anaesthesia .

It is considered a potentially serious postoperative complication that can result in physical harm and removal of intravenous catheters. As such, EA is a source of dissatisfaction for the parents of paediatric patients and their healthcare providers .

Sevoflurane is an inhalational anaesthetic used widely as a paediatric or outpatient anaesthesia due to its excellent hemodynamic stability and low blood solubility, which allows rapid induction and emergence from general anaesthesia, as well as control of the depth of anaesthesia. However, when sevoflurane is used alone it is associated with a higher incidence of emergence agitation in children. The rapid removal of residual anaesthetics due to low blood solubility of sevoflurane has been suggested to cause emergence agitation in some patients

Nalbuphine is a semi-synthetic, agonist antagonist opioid analgesic agent that acts as a partial agonist at kappa receptors and an antagonist at µ receptors, has minimal side effects, and exhibits a ceiling effect for respiratory depression .

Nalbuphine should effectively relieve postoperative pain and decrease the rate of EA in paediatric patients after sevoflurane anaesthesia.

Dexmedetomidine, a selective alpha 2 agonist, has been shown to reduce the incidence of postoperative agitation with sevoflurane anaesthesia .

Dexmedetomidine can affect the brain and spinal cord α 2-adrenergic receptor, inhibition of neural discharge to produce sedative, analgesic, and anxiolytic effects.

The Locus Coeruleus is a verified key part of the brain responsible for the regulation of arousal and sleep. Dexmedetomidine affects the brainstem locus coeruleus α 2-adrenergic receptors and produces sedative, hypnotic, and anxiolytic effects and it has also anesthetic-sparing effects without significant respiratory depression .

This study will be conducted to evaluate the effect of intravenous nalbuphine IV 0.1 mg/kg versus Dexmedetomidine IV 0.5 μg/kg on EA in paediatric patients undergoing ENT surgeries under sevoflurane anaesthesia.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11111
    • AinShams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nalbuphine group; 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; 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)
Active Comparator: Dexmedetomidine group; 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; 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) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Madlin A selwanes, M.B.B.CH, anesthesia resident at Ain shames university

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Emergence delirium
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Emergence Delirium; Delirium; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Nalbuphine
• Other Study ID Numbers: FMASU MS127/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all date should be shared once the study is published
• IPD Sharing Time Frame: Before 6/2025
• IPD Sharing Access Criteria: Free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

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