Peribulbar Block for Prevention of Oculocardiac Reflex

NCT04549844 | Unknown Phase 4

• 1 other identifier: M427
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Strabismus is a common ophthalmic problem in Egypt that usually requires surgical correction. This surgery primarily aims to improve alignment of visual axis but may be required only for cosmetic reasons. General anesthesia is mandatory for most cases however a concomitant local anesthetics administration is preferable to improve patient satisfaction, decrease postoperative analgesic requirements and reduce post-operative pain. Oculocardiac reflex is a noted serious complication that accompanies such surgeries and may be life threatening. Oculocardiac reflex (OCR) is one of the main challenges that face anesthesiologists during strabismus surgery. The incidence of OCR varies from 16 to 82 % in strabismus surgeries and this wide range does depend on the anesthetic agents, premedications, and the definition of OCR being used. Maintenance of adequate depth of anesthesia and the use of anti-cholinergic is the mainstay to reduce this risk. OCR is usually defined as a decrease in heart rate of more than 20 % from the baseline. This reflex is triggered by the pressure on the extra ocular muscles (EOM) or eyeball, orbital hematoma or trauma, the afferent limb is from orbital contents to ciliary ganglion then to the sensory nucleus of the trigeminal nerve near the fourth ventricle through the ophthalmic division of the trigeminal nerve. The main response of this reflex is transmitted through the vagus to the heart. This vagal stimulation leads to a decrease in heart rate (sinus bradycardia), contractility and arrhythmias such as atrioventricular block, ventricular fibrillation up to cardiac arrest. The incidence of the OCR decreases with age and tends to be more pronounced in young healthy patients. It has been suggested that the anesthetic agents used during surgery influence the incidence of OCR. To date, the only successful method to interrupt an OCR is to stop the EOM traction, and then proceed with caution as surgery continues. Depth of anesthesia is another presumed factor having an impact on reducing of OCR incidence. The response to surgical stimulus can be minimized or stopped with the help of peribulbar block.

Conditions

Strabismus

Keywords

Peribulbar block; Oculocardiac reflex

Outcome Measures

Primary Outcomes (1)

• The incidence of Oculocardiac reflex .

  Occurence of bradycardia with heart rate decrease by 20% from baseline value or if dysrhythmias or sinus arrest after traction on extraocular muscles

  3 minutes after traction on extraocular muscles during squint surgery

Secondary Outcomes (11)

• Degree of post operative pain

  2 hours post operatively

• Degree of post operative pain

  4 hours postoperatively

• Degree of post operative pain

  6 hours postoperatively

• Degree of post operative pain

  12 hours postoperatively

• Degree of post operative pain

  24 hours postoperatively

Other Outcomes (4)

• Patient's age

  1 hour before operation

• Patient's weight

  1 hour before operation

• Patient's height

  1 hour before operation

Study Arms (2)

the intervention group (G A)

ACTIVE COMPARATOR

Group general anaesthesia plus peribulbar block : Total 35 cases who will receive general anesthesia with peribulbar block (bupivacaine 0.5 % xylocaine 2% hyaluronidase with total volume 0.06 mg \\kg (bupivacaine : (xylocaine :hyaluronidase ) 1:1) Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery.

Drug: Bupivacaine

the control group (G B )

PLACEBO COMPARATOR

General group: Total 35 cases who will receive general anesthesia only, i.e., without peribulbar block. (Fentanyl 1µg\\kg, atracurium 0.5 mg\\kg and propofol 2mg \\kg. After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane. Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery.

Also known as: xylocaine hyaluronidase

the control group (G B ); the intervention group (G A)

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients aged 10 years to 50 years
• American society association (ASA) physical status I, II
• Patient scheduled for a unilateral strabismus surgery.

You may not qualify if:

• Refusal of local anesthesia.
• Contraindications of local anesthesia e.g. allergy or hypersensitivity to local anesthetics or orbital inflammation .
• Pregnancy
• Glaucoma
• Communication barrier between physician and patient e.g. impaired hearing, impaired mental status

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Faculty of Medicine -Fayoum University

Al Fayyum, 1234, Egypt

RECRUITING

Related Publications (2)

• Karanovic N, Carev M, Ujevic A, Kardum G, Dogas Z. Association of oculocardiac reflex and postoperative nausea and vomiting in strabismus surgery in children anesthetized with halothane and nitrous oxide. Paediatr Anaesth. 2006 Sep;16(9):948-54. doi: 10.1111/j.1460-9592.2006.01865.x.

  PMID: 16918657 BACKGROUND

• Kosaka M, Asamura S, Kamiishi H. Oculocardiac reflex induced by zygomatic fracture; a case report. J Craniomaxillofac Surg. 2000 Apr;28(2):106-9. doi: 10.1054/jcms.2000.0107.

  PMID: 10958423 BACKGROUND

MeSH Terms

Conditions

Strabismus

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Maged Labib Boulos, MD

  faculty of medicine -fayoum university

  PRINCIPAL INVESTIGATOR

• Khalid Gamal Abu eleinen, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mahmoud Ramadan Ahmed, Bch

CONTACT

1000993093; mahram35@gmail.com

Mohamed yehia Abd Elatif, MD

CONTACT

1005037929; Mya04@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesilogy

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 16, 2020
• Study Start: August 14, 2019
• Primary Completion: September 14, 2020
• Study Completion: October 14, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)