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

NCT ID: NCT04485273

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2021-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Laryngeal Mask Airway

Intervention Type: DEVICE

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.

Sevoflurane

Intervention Type: DRUG

Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.

Subtenon's Block

Intervention Type: PROCEDURE

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.

Local Anesthetic Solution and Dexmedetomedine

Intervention Type: DRUG

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)

Control Group

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

Group Type: PLACEBO_COMPARATOR

Laryngeal Mask Airway

Intervention Type: DEVICE

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.

Sevoflurane

Intervention Type: DRUG

Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.

Subtenon's Block

Intervention Type: PROCEDURE

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.

Local Anesthetic Solution

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Sevoflurane

Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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)

Intervention Type: DRUG

Local Anesthetic Solution

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

Intervention Type: DRUG

Other Intervention Names

Supraglottic Airway Device; Inhalational Anesthesia; Regional Eye Block; Marcaine and Precedex; Marcaine

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sameh Fathy

OTHER

Sponsor Role: lead

Responsible Party

Sameh Fathy

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sameh M El-Sherbiny, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura Faculty of Medicine

Locations

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

Dexmedetomedine and agitation

Identifier Type: -

Identifier Source: org_study_id