Clinical trial NCT06830564: Emergence Agitation of Sevoflurane in Pediatric
Official title: the Effect of the Low Dose Nalbuphine Versus Dexmedetomidine on the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Children Undergoing ENT Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Emergence Delirium
Keywords: Emergence delirium
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 126
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of emergence agitation after sevoflurane anaesthesia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
affiliation: anesthesia resident at Ain shames university
name: Madlin A selwanes, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References: