Clinical Trials Logo

Clinical Trial Summary

This study is conducted to evaluate importance of bispectral index (BIS) monitoring in patients undergoing strabismus surgery when using propofol in comparison to sevoflurane anesthesia regarding their effects on oculocardiac reflex, intraoperative hemodynamic stability, emergence agitation, postoperative pain, nausea and vomiting.


Clinical Trial Description

Strabismus surgery can cause unfavorable side effects during intraoperative and postoperative periods including increased risk of the oculocardiac reflex, hemodynamic instability, emergence agitation, postoperative pain, nausea and vomiting. Sevoflurane is an inhalation anesthetic widely used in pediatric anesthesia with minimal airway irritation. Propofol is an intravenous sedative-hypnotic agent with amnestic properties that causes loss of consciousness. Bispectral index monitor provide some more evidence that deeper anesthesia can provide some protection against the oculocardiac reflex. Therefore, this study is conducted to evaluate the role of BIS monitoring in comparing the use of propofol and sevoflurane anesthesia in pediatric strabismus surgery. This prospective, randomized, comparative clinical study will include 100 children who are scheduled for elective strabismus surgery under general anesthesia 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 NCT04485117
Study type Interventional
Source Mansoura University
Contact
Status Completed
Phase N/A
Start date January 1, 2020
Completion date July 21, 2020

See also
  Status Clinical Trial Phase
Completed NCT04432181 - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Completed NCT03596138 - Reliability and Reproducibility of Automated Angular Measurement in Strabismus
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Recruiting NCT04770519 - Genetic Studies of Strabismus, Nystagmus, and Associated Disorders
Completed NCT01512355 - The Effect of Dexmedetomidine on Decreasing Emergence Agitation and Delirium in Pediatric Patients Undergoing Strabismus Surgery N/A
Completed NCT00461656 - Povidone-iodine Antisepsis for Strabismus Surgery Phase 4
Completed NCT00535938 - MDs on Botox Utility (MOBILITY) N/A
Completed NCT01109459 - Multimodal Physician Intervention to Detect Amblyopia N/A
Not yet recruiting NCT06035757 - The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery Phase 4
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Recruiting NCT04416776 - Validation of the Utility of Strabismus Intelligent Diagnostic System
Recruiting NCT04353960 - The Alaska Oculocardiac Reflex Study
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1
Completed NCT01726842 - Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner N/A
Completed NCT00001143 - Development of the Eye Motor System During the First 7 Months of Life in Infants With and Without a Family History of Cross-Eye N/A
Completed NCT04303832 - Exercise Interventions of Eye Muscles Post Strabismus Surgery N/A
Completed NCT03806270 - Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery
Recruiting NCT05425589 - Adjustable Strabismus Surgery N/A
Completed NCT00559234 - Potential Research Participants for Future Studies of Inherited Eye Diseases N/A
Completed NCT02570555 - Strabismus Surgery and Driving Ability