NCT04485273

Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery

Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sameh Fathy · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

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. 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.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
DEVICE	Laryngeal Mask Airway	Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.
DRUG	Sevoflurane	Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.
PROCEDURE	Subtenon's Block	Subtenon's block is performed in the eye undergoing surgery under sterile conditions where a 19-gauge curved blunt metallic cannula (25 mm) is inserted into sub-tenon's space.
DRUG	Local Anesthetic Solution and Dexmedetomedine	The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg), in addition to dexmedetomedine (0.5 μg /kg)
DRUG	Local Anesthetic Solution	The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-01-01
• Completion: 2021-12-01
• First posted: 2020-07-24
• Last updated: 2022-06-22

Locations

1 site across 1 country: Egypt