Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol-Midazolam Versus Sevoflurane Anesthesia

February 13, 2024 updated by: Zahraa Ibrahim Zamzm, Mansoura University

Bispectral Index Monitoring In Pediatric Cataract Surgery: A Comparative Study Using Propofol- Midazolam Versus Sevoflurane Anesthesia

Ocular alignment will be studied in children having cataract surgery that will be divided into two groups, one group will be anesthetized using sevoflurane anesthesia (group A), and the other will be anesthetized by midazolam bolus and propofol infusion (total intravenous anesthesia, TIVA) (group B). in both groups depth of anesthesia will be monitored by bispectral index monitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After signing the informed consent by children parent, child will be transferred to the operating room and will be connected to pulse oximetry, non invasive blood pressure and electrocardiogram(ECG), child will be anesthetized by sevoflurane 8% for cannula insertion, then in Group A, sevoflurane will be continued with 2%, and iv atracurium 0.25mg/kg, and paracetamol 15mg/kg iv will be given. In group B, sevoflurane will be discontinued and propofol bolus1mg/kg iv, midazolam 0.05 mg/kg iv, atracurium 0.25 iv, and paracetamol 15mg/kg iv then propofol infusion will start immediately according to McFarlan protocol for manual syringe pump for pediatrics. For first 10 minutes 15mg/kg, second 10 minutes 13mg/kg, third 10 minutes 13mg/kg, fourth 10 minutes 11mg/kg, fifth 10 minutes 11mg/kg, and will be continued on this rate for the end of surgery. Bispectral index monitor(Covidien, Germany) will be attached to child forehead after cleansing it with alcohol 70%. after adequate jaw relaxation , trachea will be intubated with adequate size endotracheal tube and attached to anesthesia machine ( General electric, Carestation 650).Volume controlled ventilation (VCV) will start with tidal volume(VT) 6-8 ml/kg, respiratory rate (RR)16-20 according to end-tidal carbon dioxide (CO2)35-40mmhg. Flow of fresh gas rate 2 l/minute. standard circuit system connection for pediatric will be used. Heart rate ,peripheral oxygen saturation (SPO2), non invasive blood pressure, end-tidal carbon dioxide (ETCO2), and bispectral index monitor will be measured every 5 minutes. 6 ml/kg of ringer will be given infusion slowly.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

0-children American society of anesthesiologist (ASA )grade l, ll of both sex 0-congenital or traumatic cataract

Exclusion Criteria:

0- syndromes involving cataract. 0- children with neurologic disorders. 0- children on anti-psychotic medication. 0- hypersensitivity to any anesthetic used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sevoflurane group with BIS monitor for depth of anesthesia
child will be anesthetized with sevoflurane 2% and atracurium 0.25mg/kg and paracetamol 15mg/kg, then bispectral index will be recorded after intubation and every five minutes till end of surgery. Position of the globe will recorded every five minutes. Angle of deviation of the globe will be calculated via withdrawing horizontal line passing from the lateral and medial canthi, and another vertical one passing the medial canthus(90-0--90 degree). Bis should be 40-65 to ensure adequate depth of anesthesia. If more than 65 or less than 40, sevoflurane concentration will be adjusted till having the target range. pupillary dilation in surgical eye will be assessed after speculum insertion, 20 minutes after speculum insertion, and before speculum removal by pupil ruler((pupil gauge), whether it will be maintained or not (considered maintained if pupil size equal or more than 5mm).
Other: measuring depth of anesthesia and its relation to the globe
measuring feasibility of BIS monitor in detecting depth of anesthesia in pediatric population and whether it will be beneficial as a tool for helping anesthesiologist in maintaining central globe alignment
Active Comparator: propofol-midazolam group with BIS monitor for depth of anesthesia
Child will be anesthetized with midazolam 0.05 mg/kg IV bolus and propofol 1mg/kg IV bolus, paracetamol 15mg\kg IV infusion, and atracurium 0.25mg/kg IV bolus ,then anesthesia will be maintained with propofol infusion according to Mcfarlan protocol, then BIS will be recorded after intubation and every five minutes till end of surgery. Position of the globe will recorded every five minutes till the end of surgery. Angle of deviation will be calculated in same way as group A. Bis should be 40-65. If more than 65 or less than 40, sevoflurane concentration will be adjusted till having the target range. pupillary dilation in surgical eye will be assessed after speculum insertion, 20 minutes after speculum insertion, and before speculum removal by pupil ruler((pupil gauge) and will be observed all over the surgery with the help of surgeon feedback whether it will be maintained or not (considered maintained if pupil size equal or more than 5mm).
Other: measuring depth of anesthesia and its relation to the globe
measuring feasibility of BIS monitor in detecting depth of anesthesia in pediatric population and whether it will be beneficial as a tool for helping anesthesiologist in maintaining central globe alignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessing depth of anesthesia and its relation to ocular alignment
Time Frame: after intubation and every five minutes till end of surgery
depth of anesthesia will be measured using bispectral index monitor (BIS) monitor and position of the globe will be assessed and related to it by measuring the angle of deviation in degrees. Then, correlation the findings using pearson correlation co-effecient
after intubation and every five minutes till end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pupillary dilatation
Time Frame: after insertion of the speculum by 10 minutes and 20 minutes
pupil of surgical eye is dilated with phenylephrine 2.5%. assessing wether pupillary dilatation will be maintained during anesthesia (> or aqual to 5 mm) or not by using pupil gauge.
after insertion of the speculum by 10 minutes and 20 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
post emergence agitation
Time Frame: after extubation and for 30 minutes later.
the child will be assessed with Watcha scale. If score is 4 he is considered agitated
after extubation and for 30 minutes later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Nabil Abd-Elmagid, professor, Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

August 14, 2023

Study Completion (Actual)

November 15, 2023

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 19, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD.21.03.449.R1-2021/04/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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