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

Primary Purpose

Emergence Agitation

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laryngeal Mask Airway
Sevoflurane
Subtenon's Block
Local Anesthetic Solution and Dexmedetomedine
Local Anesthetic Solution
Sponsored by
Sameh Fathy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emergence Agitation focused on measuring Dexmedetomedine, Subtenon's Block

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesia, Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomedine Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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)
Emergence time
Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.

Secondary Outcome Measures

Changes in heart rate
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery.
Changes in mean arterial blood pressure
Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.
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.
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.
Total analgesic requirements of paracetamol
The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
First analgesic request
The time of the first analgesic request for paracetamol is recorded.
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.

Full Information

First Posted
July 21, 2020
Last Updated
June 18, 2022
Sponsor
Sameh Fathy
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1. Study Identification

Unique Protocol Identification Number
NCT04485273
Brief Title
Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery
Official Title
Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sameh Fathy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation
Keywords
Dexmedetomedine, Subtenon's Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomedine Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected.
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway
Other Intervention Name(s)
Supraglottic Airway Device
Intervention Description
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
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Inhalational Anesthesia
Intervention Description
Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Subtenon's Block
Other Intervention Name(s)
Regional Eye Block
Intervention Description
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
Drug
Intervention Name(s)
Local Anesthetic Solution and Dexmedetomedine
Other Intervention Name(s)
Marcaine and Precedex
Intervention Description
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
Intervention Name(s)
Local Anesthetic Solution
Other Intervention Name(s)
Marcaine
Intervention Description
The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).
Primary Outcome Measure Information:
Title
Changes in postoperative emergence agitation scale
Description
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)
Time Frame
Up to 30 minutes after surgery
Title
Emergence time
Description
Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.
Time Frame
Up to 30 minutes after surgery
Secondary Outcome Measure Information:
Title
Changes in heart rate
Description
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery.
Time Frame
Up to the end of the surgery
Title
Changes in mean arterial blood pressure
Description
Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.
Time Frame
Up to the end of the surgery
Title
Incidence of oculocardiac reflex
Description
If there is dysrhythmia or rapid reduction in HR by more than 25% from the baseline, it is considered as an oculocardiac reflex.
Time Frame
Up to the end of the surgery
Title
Changes in pain scores
Description
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.
Time Frame
Up to 24 hours after the procedure
Title
Total analgesic requirements of paracetamol
Description
The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Time Frame
Up to 24 hours after the procedure
Title
First analgesic request
Description
The time of the first analgesic request for paracetamol is recorded.
Time Frame
Up to 24 hours after the procedure
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.
Time Frame
Up to 24 hours after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh M El-Sherbiny, MD
Organizational Affiliation
Mansoura Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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