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NCT Number: NCT04485273

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

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.

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Key information

Conditions

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

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Supraglottic Airway Device

Sevoflurane

Drug

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

Other names: Inhalational Anesthesia

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.

Other names: Regional Eye Block

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)

Other names: Marcaine and Precedex

Local Anesthetic Solution

Drug

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

Other names: Marcaine

Primary outcomes

  1. Changes in postoperative emergence agitation scale

    Time frame: Up to 30 minutes after surgery

    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)

  2. Emergence time

    Time frame: Up to 30 minutes after surgery

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

Secondary outcomes

  1. Changes in heart rate

    Time frame: Up to the end of the surgery

    Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery.

  2. Changes in mean arterial blood pressure

    Time frame: Up to the end of the surgery

    Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.

  3. Incidence of oculocardiac reflex

    Time frame: Up to the end of the surgery

    If there is dysrhythmia or rapid reduction in HR by more than 25% from the baseline, it is considered as an oculocardiac reflex.

  4. Changes in pain scores

    Time frame: Up to 24 hours after the procedure

    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.

  5. Total analgesic requirements of paracetamol

    Time frame: Up to 24 hours after the procedure

    The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.

  6. First analgesic request

    Time frame: Up to 24 hours after the procedure

    The time of the first analgesic request for paracetamol is recorded.

  7. Incidence of postoperative nausea and vomiting

    Time frame: Up to 24 hours after the procedure

    Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2020
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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