Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04485273
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2020-07-21
Brief Title:
Effect of Dexmedetomedine in Subtenons Block on Emergence Agitation in Pediatric Strabismus Surgery
Sponsor:
Sameh Fathy
Organization:
Mansoura University
Study Overview
Official Title:
Effect of Dexmedetomedine in Subtenons Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia
Status:
COMPLETED
Status Verified Date:
2022-06
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:
The study is conducted to evaluate the effects of dexmedetomedine in subtenons block in conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation intraoperative hemodynamic stability postoperative pain nausea and vomiting in patients undergoing strabismus surgery
Detailed Description:
Emergency agitation is a clinical status of postoperative excitement or emergence delirium when the patient is awake but is disorientated It is described as mental disturbances that consist of confusion hallucinations and delusions which is manifested by restless involuntary physical activity and thrashing about the bed Its incidence has been observed especially in pediatric ophthalmology care units due to many factors such as pain mental status time of operation age lack of ability to see outside and a history of previous hyperthermia Strabismus surgery is one of the most frequently performed pediatric ocular operations However it can cause unfavorable side effects during intraoperative and postoperative periods Typically the major problems associated with strabismus surgeries include increased risk of the oculocardiac reflex postoperative pain nausea and vomiting Subtenons block is one of the regional anesthetic techniques used in ocular surgery Dexmedetomidine has been used as an adjuvant to local anesthetics for regional anesthesia in various clinical fields including the subtenons blockThere is evidence that dexmedetomidine decreases the incidence of agitation after sevoflurane anesthesia in children undergoing different surgical procedures Therefore this study is conducted to evaluate the effect of dexmedetomedine in subtenons block on emergence agitation in pediatric strabismus surgery under sevoflurane anesthesia
This prospective randomized clinical study includes 100 children who are scheduled for elective strabismus surgery under general surgery in Mansoura ophthalmology center Informed written consent is obtained from parents of all subjects in the study after ensuring confidentialityThe study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery Patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization methodThe collected data are coded processed and analyzed using SPSS program All data are considered statistically significant if P value is 005
This prospective randomized clinical study includes 100 children who are scheduled for elective strabismus surgery under general surgery in Mansoura ophthalmology center Informed written consent is obtained from parents of all subjects in the study after ensuring confidentialityThe study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery Patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization methodThe collected data are coded processed and analyzed using SPSS program All data are considered statistically significant if P value is 005
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