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NCT Number: NCT04485117

Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring

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.

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Key information

Conditions

Strabismus Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

3 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

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.

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 elective Strabismus surgery.

Exclusion criteria

  • Parental refusal of consent.
  • 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.
  • Children with previous surgery in the eye.

Treatment and study plan

Bispectral Index Monitor

Device

Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.

Other names: BIS Monitoring

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

Anesthesia is induced inhalationally by face mask with 8% sevoflurane in 100% oxygen, then decreased to 2-3% in 40% oxygen thoroughout the operation for maintenance of anesthesia.

Other names: Inhalational Anesthesia

Propofol

Drug

Anesthesia is induced by propofol (2mg/kg), then maintained using an infusion of fixed concentration (10-15 mg/kg/h) as titrated by the anesthesiologist .

Other names: Intravenous Anesthesia

Primary outcomes

  1. Incidence of oculocardiac reflex

    Time frame: Up to the end of the surgery

    Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.

Secondary outcomes

  1. Changes in bispectral index

    Time frame: Up to the end of the surgery

    Bispectral index values (0-100) are recorded every five minutes until the end of the surgery

  2. 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

  3. Changes in mean arterial blood pressure

    Time frame: Up to the end of the surgery

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

  4. 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)

  5. Changes in postoperative pain score

    Time frame: Up to 24 hours after surgery

    Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours for 24 hours after surgery.

  6. First analgesic request

    Time frame: Up to 24 hours after surgery

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

  7. Total analgesic requirements of paracetamol

    Time frame: Up to 24 hours after surgery

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

  8. Incidence of postoperative nausea and vomiting

    Time frame: Up to 24 hours after surgery

    Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.

Sponsors and collaborators

Lead sponsor

Sameh Fathy

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2020
Registry last updated
Jun 10, 2021

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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