The Effect of the Low Dose Nalbuphine Versus Dexmedetomidine on the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Children Undergoing ENT Surgeries
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- incidence of emergence agitation after sevoflurane anaesthesia
Study Overview
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
prospective, randomized, double-blinded, comparative study
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: we will give the patient 0.1 mg nalbuphine 15 min before the end of the procedure (Drug)
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
Intervention: we will give the patient 0.5 mg dexmedetomidine 15 min before the end of the procedure (Drug)
Outcomes
Primary Outcomes
incidence of emergence agitation after sevoflurane anaesthesia
Time Frame: 6 months
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
Secondary Outcomes
No secondary outcomes reported