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Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia
The study is conducted to evaluate the effects of dexmedetomedine in subtenon's 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.
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. Subtenon's 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 subtenon's block.There 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 subtenon's 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 confidentiality.The 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 method.The collected data are coded, processed, and analyzed using SPSS program. All data are considered statistically significant if P value is ≤ 0.05.
Age
2 - 8 years
Sex
ALL
Healthy Volunteers
No
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
Start Date
July 1, 2019
Primary Completion Date
January 1, 2021
Completion Date
December 1, 2021
Last Updated
June 22, 2022
100
ACTUAL participants
Laryngeal Mask Airway
DEVICE
Sevoflurane
DRUG
Subtenon's Block
PROCEDURE
Local Anesthetic Solution and Dexmedetomedine
DRUG
Local Anesthetic Solution
DRUG
Lead Sponsor
Sameh Fathy
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06648122