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

NCT04485273 | Completed

• 1 other identifier: Dexmedetomedine and agitation
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Agitation

Keywords

Dexmedetomedine; Subtenon's Block

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Changes in heart rate

  Up to the end of the surgery

• Changes in mean arterial blood pressure

  Up to the end of the surgery

• Incidence of oculocardiac reflex

  Up to the end of the surgery

• Changes in pain scores

  Up to 24 hours after the procedure

• Total analgesic requirements of paracetamol

  Up to 24 hours after the procedure

Study Arms (2)

Dexmedetomedine Group

ACTIVE COMPARATOR

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.

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

Control Group

PLACEBO COMPARATOR

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

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

Interventions

Laryngeal Mask Airway 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.

Also known as: Supraglottic Airway Device

Control Group; Dexmedetomedine Group

Sevoflurane DRUG

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

Also known as: Inhalational Anesthesia

Control Group; Dexmedetomedine Group

Subtenon's Block 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.

Also known as: Regional Eye Block

Control Group; Dexmedetomedine Group

Local Anesthetic Solution and Dexmedetomedine 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)

Also known as: Marcaine and Precedex

Dexmedetomedine Group

Local Anesthetic Solution DRUG

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

Also known as: Marcaine

Control Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sameh Fathy: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Laryngeal Masks; Sevoflurane; Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Anilides; Amides; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sameh M El-Sherbiny, MD

  Mansoura Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)