Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04485273
Study type Interventional
Source Mansoura University
Contact
Status Completed
Phase N/A
Start date July 1, 2019
Completion date December 1, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04807998 - Risk Factors for Pediatric Emergence Agitation and Analysis of Serum or Urine Metabonomics in Children With Agitation
Completed NCT00990769 - The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children N/A
Not yet recruiting NCT03596775 - Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children Early Phase 1
Active, not recruiting NCT03846284 - Caudal Versus Intravenous Magnesium Sulfate on Emergence Agitation After Sevoflurane In Children. N/A
Completed NCT03062488 - Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery Early Phase 1
Completed NCT05601674 - The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty N/A
Completed NCT01737593 - Can Acetaminophen Given 1-2 Hours to Children Before Ear Tube Surgery Reduce Agitation After Anesthesia? Phase 4
Not yet recruiting NCT05624424 - Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery Phase 4
Completed NCT04168879 - Sphenopalatine Ganglion Block for Nasal Surery N/A
Not yet recruiting NCT06079710 - Effect of Intraoperative and Awakening Electroencephalogram on Awakening Agitation After General Anesthesia in Children
Recruiting NCT04142840 - Dexmedetomidine and Propofol in the Treatment of Emergence Agitation Early Phase 1
Completed NCT04844333 - Effect of Extubation Under Deep Anesthesia on Emergence Agitation of Nasal Surgery N/A
Recruiting NCT02169843 - Small Doses of Dexmedetomidine for Emergence Agitation Phase 4
Completed NCT04820595 - Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial
Not yet recruiting NCT06312618 - Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation Phase 4
Recruiting NCT05766436 - Nebulized Dexmedetomidine VS ODF Melatonin for Peri Operative Anxiety and Emergence Agitation in Pediatric Day Surgery N/A
Completed NCT03134547 - A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block N/A
Completed NCT03807011 - Emergence Agitation in Pediatric Strabismus Surgery N/A
Completed NCT03179293 - Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation Phase 4
Completed NCT05223010 - Melatonin for Pediatric Emergence Agitation Phase 4