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

Sameh Fathy

Status: Completed

Conditions: Emergence Agitation

Treatments: Drug: Local Anesthetic Solution; Drug: Sevoflurane; Drug: Local Anesthetic Solution and Dexmedetomedine; Procedure: Subtenon's Block; Device: Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT04485273

Dexmedetomedine and agitation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiology (ASA) I and II patients.
• Scheduled for strabismus surgery.

Exclusion criteria

• Parental refusal of consent.
• Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
• Hyperactive airway disease or respiratory diseases.
• Children with developmental delays, mental or neurological disorders.
• Bleeding or coagulation diathesis.
• History of known sensitivity to the used anesthetics.
• Previous surgery in the same eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Dexmedetomedine Group

Active Comparator group

Description:

Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected, in addition to dexmedetomedine.

Treatment:

Device: Laryngeal Mask Airway

Procedure: Subtenon's Block

Drug: Local Anesthetic Solution and Dexmedetomedine

Drug: Sevoflurane

Control Group

Placebo Comparator group

Description:

Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected.

Treatment:

Device: Laryngeal Mask Airway

Procedure: Subtenon's Block

Drug: Local Anesthetic Solution

Drug: Sevoflurane