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

Primary Purpose

Strabismus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bispectral Index Monitor
Laryngeal Mask Airway
Sevoflurane
Propofol
Sponsored by
Sameh Fathy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Strabismus focused on measuring Bispectral Index Monitoring

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Anesthesia, Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Sevoflurane Group

Propofol Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in bispectral index
Bispectral index values (0-100) are recorded every five minutes until the end of the surgery
Changes in heart rate
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery
Changes in mean arterial blood pressure
Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery
Changes in postoperative emergence agitation scale
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)
Changes in postoperative pain score
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.
First analgesic request
The time of the first analgesic request for paracetamol is recorded.
Total analgesic requirements of paracetamol
The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.

Full Information

First Posted
July 21, 2020
Last Updated
June 8, 2021
Sponsor
Sameh Fathy
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1. Study Identification

Unique Protocol Identification Number
NCT04485117
Brief Title
Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
Official Title
Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sameh Fathy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
Keywords
Bispectral Index Monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane Group
Arm Type
Active Comparator
Arm Description
Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring.
Arm Title
Propofol Group
Arm Type
Active Comparator
Arm Description
Laryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring.
Intervention Type
Device
Intervention Name(s)
Bispectral Index Monitor
Other Intervention Name(s)
BIS Monitoring
Intervention Description
Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway
Other Intervention Name(s)
Supraglottic Airway Device
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Inhalational Anesthesia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Intravenous Anesthesia
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Incidence of oculocardiac reflex
Description
Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.
Time Frame
Up to the end of the surgery
Secondary Outcome Measure Information:
Title
Changes in bispectral index
Description
Bispectral index values (0-100) are recorded every five minutes until the end of the surgery
Time Frame
Up to the end of the surgery
Title
Changes in heart rate
Description
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery
Time Frame
Up to the end of the surgery
Title
Changes in mean arterial blood pressure
Description
Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery
Time Frame
Up to the end of the surgery
Title
Changes in postoperative emergence agitation scale
Description
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)
Time Frame
Up to 30 minutes after surgery
Title
Changes in postoperative pain score
Description
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.
Time Frame
Up to 24 hours after surgery
Title
First analgesic request
Description
The time of the first analgesic request for paracetamol is recorded.
Time Frame
Up to 24 hours after surgery
Title
Total analgesic requirements of paracetamol
Description
The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Time Frame
Up to 24 hours after surgery
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.
Time Frame
Up to 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh M El-Sherbiny, MD
Organizational Affiliation
Mansoura Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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