Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 07/20/2020 |
| Estimated Enrollment Submitted: | 07/20/2020 |
| First Posted: | 07/23/2020 |
| Last Update Submitted: | 07/22/2020 |
| Last Update Posted: | 07/26/2020 |
| Actual Study Start Date: | 06/30/2019 |
| Estimated Primary Completion Date: | 04/30/2020 |
| Estimated Study Completion Date: | 06/30/2020 |
Condition or disease
Intervention/treatment
Device: Laryngeal Mask Airway
Drug: Sevoflurane
Procedure: Subtenon's Block
Drug: Dexmedetomedine Group
Drug: Control Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Dexmedetomedine Group 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. | Drug: Dexmedetomedine Group 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) |
| Placebo Comparator: Control Group Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected. | Drug: Control Group The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg). |
Eligibility Criteria
| Ages Eligible for Study | 1 Year To 1 Year |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Changes in postoperative emergence agitation scale [Up to 30 minutes after surgery]
2. Emergence time [Up to 30 minutes after surgery]
Secondary Outcome Measures
1. Changes in heart rate [Up to the end of the surgery]
2. Changes in mean arterial blood pressure [Up to the end of the surgery]
3. Incidence of oculocardiac reflex [Up to the end of the surgery]
4. Changes in pain scores [Up to 24 hours after the procedure]
5. Total analgesic requirements of paracetamol [Up to 24 hours after the procedure]
6. First analgesic request [Up to 24 hours after the procedure]
7. Incidence of postoperative nausea and vomiting [Up to 24 hours after the procedure]
