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

NCT04485117 | Completed

• 1 other identifier: BIS Monitoring in Strabismus
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Strabismus

Keywords

Bispectral Index Monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of oculocardiac reflex

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

  Up to the end of the surgery

Secondary Outcomes (8)

• Changes in bispectral index

  Up to the end of the surgery

• Changes in heart rate

  Up to the end of the surgery

• Changes in mean arterial blood pressure

  Up to the end of the surgery

• Changes in postoperative emergence agitation scale

  Up to 30 minutes after surgery

• Changes in postoperative pain score

  Up to 24 hours after surgery

Study Arms (2)

Sevoflurane Group

ACTIVE COMPARATOR

Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.

Device: Bispectral Index Monitor; Device: Laryngeal Mask Airway; Drug: Sevoflurane

Propofol Group

ACTIVE COMPARATOR

Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.

Device: Bispectral Index Monitor; Device: Laryngeal Mask Airway; Drug: Propofol

Interventions

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.

Also known as: BIS Monitoring

Propofol Group; Sevoflurane Group

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

Propofol Group; Sevoflurane Group

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.

Also known as: Inhalational Anesthesia

Sevoflurane Group

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 .

Also known as: Intravenous Anesthesia

Propofol Group

Eligibility Criteria

• Age: 3 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 elective Strabismus surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sameh Fathy: lead

Study Sites (1)

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Strabismus

Interventions

Consciousness Monitors; Laryngeal Masks; Sevoflurane; Propofol; Anesthesia, Intravenous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Anesthesia; Anesthesia and Analgesia

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: January 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 21, 2020
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)