StrabismusNCT04485117
Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
A study testing Bispectral Index Monitor, Laryngeal Mask Airway and Sevoflurane in people with Strabismus, run by Sameh Fathy at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Strabismus
- What is being tested?
- Bispectral Index Monitor, Laryngeal Mask Airway and Sevoflurane
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 21 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for elective Strabismus surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
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.
Read the 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.
- Conditions
- Strabismus
- Being tested
- Bispectral Index Monitor, Laryngeal Mask Airway, Sevoflurane, Propofol
- Keywords
- Bispectral Index Monitoring
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index MonitorDevice
Also called BIS Monitoring
Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.
Laryngeal Mask AirwayDevice
Also called Supraglottic 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.
SevofluraneDrug
Also called Inhalational Anesthesia
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.
PropofolDrug
Also called Intravenous Anesthesia
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 .
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Active comparator | Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring. Receives: 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. Receives: Device: Bispectral Index Monitor; Device: Laryngeal Mask Airway; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oculocardiac reflex
Any dysrhythmia or rapid reduction in HR by more than 25% from the baseline is taken as oculocardiac reflex.
Measured: Up to the end of the surgery
Secondary outcomes (8)
Changes in bispectral index
Bispectral index values (0-100) are recorded every five minutes until the end of the surgery
Measured: Up to 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
Measured: Up to 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
Measured: Up to 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)
Measured: Up to 30 minutes after surgery
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.
Measured: Up to 24 hours after surgery
First analgesic request
The time of the first analgesic request for paracetamol is recorded.
Measured: Up to 24 hours after surgery
Total analgesic requirements of paracetamol
The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Measured: Up to 24 hours after surgery
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.
Measured: Up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- Sameh M El-Sherbiny, MD, Principal investigator, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485117
- Sponsor's protocol ID
- BIS Monitoring in Strabismus
- Status last verified
- Jun 2021
- First submitted
- 21 Jul 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol Versus Sevoflurane Anesthesia in Pediatric Strabismus Surgery: Feasibility of BIS Monitoring
- ClinicalTrials.gov ID
- NCT04485117
- Acronym / sponsor ID
- BIS Monitoring in Strabismus
- Conditions
- Strabismus
- Keywords
- Bispectral Index Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Active comparator | Device: Bispectral Index Monitor, Device: Laryngeal Mask Airway, Drug: SevofluraneLaryngeal mask airway is inserted and anesthesia is maintained with sevoflurane anesthesia under BIS monitoring. |
| Propofol Group | Active comparator | Device: Bispectral Index Monitor, Device: Laryngeal Mask Airway, Drug: PropofolLaryngeal mask airway is inserted and anesthesia is maintained with propofol infusion under BIS monitoring. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for elective Strabismus surgery.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral Index MonitorAlso: BIS MonitoringBispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab. | Device | Propofol Group, Sevoflurane Group |
| Laryngeal Mask AirwayAlso: Supraglottic Airway DeviceCapnography 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. | Device | Propofol Group, Sevoflurane Group |
| SevofluraneAlso: Inhalational AnesthesiaAnesthesia 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. | Drug | Sevoflurane Group |
| PropofolAlso: Intravenous AnesthesiaAnesthesia is induced by propofol (2mg/kg), then maintained using an infusion of fixed concentration (10-15 mg/kg/h) as titrated by the anesthesiologist . | Drug | Propofol Group |
Primary outcome
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.
8 secondary outcomes
Changes in bispectral index
Time frame: Up to the end of the surgery
Changes in heart rate
Time frame: Up to the end of the surgery
Changes in mean arterial blood pressure
Time frame: Up to the end of the surgery
Changes in postoperative emergence agitation scale
Time frame: Up to 30 minutes after surgery
Changes in postoperative pain score
Time frame: Up to 24 hours after surgery
First analgesic request
Time frame: Up to 24 hours after surgery
Total analgesic requirements of paracetamol
Time frame: Up to 24 hours after surgery
Incidence of postoperative nausea and vomiting
Time frame: Up to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh M El-Sherbiny, MD principal investigator
Mansoura Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral Index Monitor, Laryngeal Mask Airway and Sevoflurane in people with Strabismus, run by Sameh Fathy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oculocardiac reflex (time frame: Up to the end of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.