Emergence Agitation of Sevoflurane in Pediatric

NCT ID: NCT06830564

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-11-01

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.

Conditions

Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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) .

Interventions

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)

Intervention Type: 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) .

Intervention Type: DRUG

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Madlin A selwanes, M.B.B.CH

Role: PRINCIPAL_INVESTIGATOR

anesthesia resident at Ain shames university

Locations

Ainshams University

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

FMASU MS127/2024

Identifier Type: -

Identifier Source: org_study_id