Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306040
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-28
Brief Title:
Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Effect of Intravenous Nalbuphine Versus Magnesium Sulfate on Emergence Agitation in Pediatric Patients Scheduled for Hypospadias Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary outcome Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium PAED scales
Secondary outcome
Therefore we designed a prospective randomized double-blind single center study to investigate whether nalbuphine andor magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia In addition the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study Post-operative extubating time interaction time open eye time and emergence time incidence of post-operative vomiting PONV laryngospasm breath-holding coughing oxygen desaturation and cardiac arrhythmias
Face Legs Activity Cry and Consola Bility FLACC scale is used to determine post-operative pain score
Parental satisfaction scores
Secondary outcome
Therefore we designed a prospective randomized double-blind single center study to investigate whether nalbuphine andor magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia In addition the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study Post-operative extubating time interaction time open eye time and emergence time incidence of post-operative vomiting PONV laryngospasm breath-holding coughing oxygen desaturation and cardiac arrhythmias
Face Legs Activity Cry and Consola Bility FLACC scale is used to determine post-operative pain score
Parental satisfaction scores
Detailed Description:
Emergence agitation EA also referred to as emergence delirium emergence excitement or inadequate emergence is a frequent post-operative complication in pediatric patients receiving inhalational anesthetics Its defined as an acute and fluctuating alteration of mental state and manifesting as agitation confusion disorientation and hyperactivity during the transition from unconsciousness to full wakefulness The incidence of EA is reported to be up to 20 in adult patients and up to 80 in children
Although EA is self-limiting it can induce potential problems in children such as self-injury bleeding and cracking of the wound falling off of the indwelling catheter and falling off of the bed which can cause some difficulties for medical staff and serious anxiety for family members In addition children with EA are at a higher risk of post-hospitalization behavioral changes which may last longer Furthermore EA treatment increases the burden on healthcare providers and increases the medical expenses of patients EA commonly occurs after the most common surgeries in children like adenoidectomy tonsillectomy hernioplasty and hypospadias repair Therefore implementing effective measures to prevent EA in children undergoing these types of surgeries is crucial Although the underlying mechanisms of EA remain unclear the mechanisms may be related to pre-operative anxiety inhaled anesthetics sevoflurane or desflurane surgery type ophthalmology or otolaryngology procedure and younger age
Some pharmacological interventions have been used to prevent and treat EA Previous studies have demonstrated that propofol benzodiazepines α2 agonists and opioids can prevent EA in children to varying degrees However these medications may lead to respiratory depression delay in anesthesia recovery and post-anesthesia care unit stay and other adverse reactions Thus the most favorable prophylactic treatment to decrease such an incidence remains unknown and the ideal approaches to prevent EA merit further exploration
Nalbuphine is a synthetic opioid receptor agonist-antagonist agonist К receptor antagonistic part μ receptor that can produce a central analgesic effect and partial sedation Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent and other alternative treatments have been insufficient The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect Owing to these advantages it is widely used in pediatric surgical analgesia
Magnesium sulphate an antagonist of N-methyl-D-aspartate NMDA glutamate receptors has been reported to improve hypo-magnesia and pre-eclampsia Recently magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia Magnesium sulphate is a medication used to manage and treat multiple clinical conditions
Although EA is self-limiting it can induce potential problems in children such as self-injury bleeding and cracking of the wound falling off of the indwelling catheter and falling off of the bed which can cause some difficulties for medical staff and serious anxiety for family members In addition children with EA are at a higher risk of post-hospitalization behavioral changes which may last longer Furthermore EA treatment increases the burden on healthcare providers and increases the medical expenses of patients EA commonly occurs after the most common surgeries in children like adenoidectomy tonsillectomy hernioplasty and hypospadias repair Therefore implementing effective measures to prevent EA in children undergoing these types of surgeries is crucial Although the underlying mechanisms of EA remain unclear the mechanisms may be related to pre-operative anxiety inhaled anesthetics sevoflurane or desflurane surgery type ophthalmology or otolaryngology procedure and younger age
Some pharmacological interventions have been used to prevent and treat EA Previous studies have demonstrated that propofol benzodiazepines α2 agonists and opioids can prevent EA in children to varying degrees However these medications may lead to respiratory depression delay in anesthesia recovery and post-anesthesia care unit stay and other adverse reactions Thus the most favorable prophylactic treatment to decrease such an incidence remains unknown and the ideal approaches to prevent EA merit further exploration
Nalbuphine is a synthetic opioid receptor agonist-antagonist agonist К receptor antagonistic part μ receptor that can produce a central analgesic effect and partial sedation Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent and other alternative treatments have been insufficient The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect Owing to these advantages it is widely used in pediatric surgical analgesia
Magnesium sulphate an antagonist of N-methyl-D-aspartate NMDA glutamate receptors has been reported to improve hypo-magnesia and pre-eclampsia Recently magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia Magnesium sulphate is a medication used to manage and treat multiple clinical conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None