Emergence Agitation of Sevoflurane in Pediatric

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Emergence Delirium

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06830564

FMASU MS127/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups

Nalbuphine group

Active Comparator group

Description:

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

Treatment:

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

Dexmedetomidine group

Active Comparator group

Description:

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

Treatment:

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