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

Strabismus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04485117
• Other study ID #: BIS Monitoring in Strabismus
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 21, 2020

Study information

• Verified date: June 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and vomiting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 21, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Strabismus

Intervention

Device:
• Bispectral Index Monitor
Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.
• Laryngeal Mask Airway
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.

Drug:
• Sevoflurane
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.
• Propofol
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 .

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Sameh Fathy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in bispectral index	Bispectral index values (0-100) are recorded every five minutes until the end of the surgery	Up to the end of the surgery
Secondary	Changes in heart rate	Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery	Up to the end of the surgery
Secondary	Changes in mean arterial blood pressure	Mean blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery	Up to the end of the surgery
Secondary	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)	Up to 30 minutes after surgery
Secondary	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.	Up to 24 hours after surgery
Secondary	First analgesic request	The time of the first analgesic request for paracetamol is recorded.	Up to 24 hours after surgery
Secondary	Total analgesic requirements of paracetamol	The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.	Up to 24 hours after surgery
Secondary	Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting is assessed during the first 24 hours post-operatively.	Up to 24 hours after surgery