Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656455
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Two Anesthetic Protocols Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for Eye Examination Under Anesthesia in Children
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to find out the optimal technique of anesthesia for eye examination in children The main question it aims to answer is
Is propofol infusion and simple oxygen facemask associated with earlier discharge from the operating room and hence rapid turnover and greater efficiency compared to sevoflurane via LMA Researchers will compare time to discharge from the operating room to see if eye examination for children less than 7 years using a propofol infusion pump based anesthesia and simple oxygen facemask results in a shorter discharge time from the operating room in comparison with sevoflurane via LMA
Participants will will be assigned to receive general anesthesia by one of two treatment groups
Is propofol infusion and simple oxygen facemask associated with earlier discharge from the operating room and hence rapid turnover and greater efficiency compared to sevoflurane via LMA Researchers will compare time to discharge from the operating room to see if eye examination for children less than 7 years using a propofol infusion pump based anesthesia and simple oxygen facemask results in a shorter discharge time from the operating room in comparison with sevoflurane via LMA
Participants will will be assigned to receive general anesthesia by one of two treatment groups
Detailed Description:
Children younger than 5 years can be uncooperative during an examination and may render it impossible The main objective of anesthesia for ophthalmic examination is to provide ideal conditions for optimal exam with a quick onset and offset of anesthesia as well as rapid recovery and early discharge Two commonly used sedation techniques for young children are sevoflurane via laryngeal mask airway LMA or propofol infused intravenously Both have been shown to be safe and effective and allow rapid changes in anesthesia depth and minimal postoperative morbidity However their induction emergence characteristics and side effect profiles may differ From previous studies it is still not evident whether propofol infusion using oxygen facemask or sevoflurane administration via LMA is superior with respect to earlier discharge from operating room in children undergoing eye examination under anesthesia EUA
In the literature there are no studies directly comparing those two different techniques for ophthalmic examination
The aim of this study is to find out the optimal technique of anesthesia for eye examination in children resulting in earlier discharge from the operating room thus decreasing the turnover time between cases and providing optimal surgical conditions without interfering with the well-being of the child or compromising the airway security
In a prospective randomized study a total sample of 60 children scheduled for eye examination under anesthesia 30 in each arm of the study aged between 1-7 years with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive general anesthesia by one of two treatment groups After induction with sevoflurane 8 in oxygen patients randomized to group S will be given propofol 2 mgkg and fentanyl 1µgkg intravenously and anesthesia will be maintained with sevoflurane via LMA Patients randomized to group P will be given propofol 1 mgkg and fentanyl 1µgkg intravenously and anesthesia will be maintained with a continuous infusion of propofol 200 µgkgmin with oxygen 3 Lmin via simple mask and oral airway if needed In both groups sevoflurane concentration or propofol infusion will be titrated to keep optimal conditions The primary outcome is time to discharge from the operating room Secondary outcomes are surgical conditions respiratory events agitation and other side effects as well as recovery times Normally distributed data will be summarized as mean SD and nonnormally distributed data will be summarized as median interquartile range
It is believed that propofol infusion and simple oxygen facemask will be associated with earlier discharge from the operating room and hence rapid turnover and greater efficiency compared to sevoflurane via LMA This study would have an impact on the current practice for pediatric ophthalmic EUA and may help find out the best technique that decreases the turnover time between cases resulting in higher operating time efficiency while providing optimal surgical conditions and patients safety
In the literature there are no studies directly comparing those two different techniques for ophthalmic examination
The aim of this study is to find out the optimal technique of anesthesia for eye examination in children resulting in earlier discharge from the operating room thus decreasing the turnover time between cases and providing optimal surgical conditions without interfering with the well-being of the child or compromising the airway security
In a prospective randomized study a total sample of 60 children scheduled for eye examination under anesthesia 30 in each arm of the study aged between 1-7 years with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive general anesthesia by one of two treatment groups After induction with sevoflurane 8 in oxygen patients randomized to group S will be given propofol 2 mgkg and fentanyl 1µgkg intravenously and anesthesia will be maintained with sevoflurane via LMA Patients randomized to group P will be given propofol 1 mgkg and fentanyl 1µgkg intravenously and anesthesia will be maintained with a continuous infusion of propofol 200 µgkgmin with oxygen 3 Lmin via simple mask and oral airway if needed In both groups sevoflurane concentration or propofol infusion will be titrated to keep optimal conditions The primary outcome is time to discharge from the operating room Secondary outcomes are surgical conditions respiratory events agitation and other side effects as well as recovery times Normally distributed data will be summarized as mean SD and nonnormally distributed data will be summarized as median interquartile range
It is believed that propofol infusion and simple oxygen facemask will be associated with earlier discharge from the operating room and hence rapid turnover and greater efficiency compared to sevoflurane via LMA This study would have an impact on the current practice for pediatric ophthalmic EUA and may help find out the best technique that decreases the turnover time between cases resulting in higher operating time efficiency while providing optimal surgical conditions and patients safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None