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

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485273
• Other study ID #: Dexmedetomedine and agitation
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: June 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation
• Strabismus

Intervention

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)
• Local Anesthetic Solution
The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Sameh Fathy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in postoperative emergence agitation scale	Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)	Up to 30 minutes after surgery
Primary	Emergence time	Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.	Up to 30 minutes after surgery
Secondary	Changes in heart rate	Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery.	Up to the end of the surgery
Secondary	Changes in mean arterial blood pressure	Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.	Up to the end of the surgery
Secondary	Incidence of oculocardiac reflex	If there is dysrhythmia or rapid reduction in HR by more than 25% from the baseline, it is considered as an oculocardiac reflex.	Up to the end of the surgery
Secondary	Changes in pain scores	Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours up to 24 hours after the procedure.	Up to 24 hours after the procedure
Secondary	Total analgesic requirements of paracetamol	The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.	Up to 24 hours after the procedure
Secondary	First analgesic request	The time of the first analgesic request for paracetamol is recorded.	Up to 24 hours after the procedure
Secondary	Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.	Up to 24 hours after the procedure