Anesthesia, Local Clinical Trial
Official title:
A Comparison Between The Effects Of Peribulbar And Sub-tenon Blocks Combined With General Anesthesia On The Incidence Of Oculocardiac Reflex (OCR) During Pediatric Strabismus Surgery: A Double Blinded Randomised Control Study
The aim of this study is to compare between peribulbar block and subtenon block as an adjunct to general anesthesia in children undergoing strabismus surgery on oculocardiac reflex (OCR), post-operative analgesia and postoperative vomiting. Both techniques will be compared to intra-operative intravenous (IV) paracetamol combined with general anesthesia as a sole anesthetic technique.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | March 30, 2024 |
Est. primary completion date | March 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 13 Years |
Eligibility | Inclusion Criteria: - Participants were children (6-13 years), ASA I-II patients, scheduled to undergo strabismus surgery. Exclusion Criteria: - Children with tumors or infections of the orbit, raised intraocular pressure more than 20 mm Hg, axial length more than 28 mm, eye injury, airway abnormalities or who were blind in the eye other than that which was to be operated on were excluded. Other exclusion criteria included patients undergoing revision surgery, known allergy to local anesthetics or non-steroidal antiinflammatory drugs (NSAIDs), steroid therapy, parental refusal to participate and patients with INR more than 1.5 or with platelets less than 100. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University faculty of medicine | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Post-operative pain using the MOPS | pain assessed using the MOPS | 4 hours | |
Other | Post-operative analgesia requirements | pethidine 0.5 mg/kg was administered IV | 4 hours | |
Other | The incidence of POV using numeric scoring | using Numeric scoring at 30 minutes and 2h post-operative | 2 hours | |
Other | Complications resulting from orbital regional anesthesia were recorded | e.g.: subconjunctival hemorrhage, local anesthetic toxicity, chemosis, optic neuropathy, extra-ocular muscle paresis | 2 hours | |
Other | Total intraoperative atropine requirements | Brady arrhythmias intraoperatively which are the most common presentation of OCR was considered when an acute decrease in heart rate below 60 beats/min and was treated by asking the surgeon to stop stimulation and giving intravenous atropine (0.01 mg. kg) | 2 hours | |
Primary | The incidence of intraoperative oculocardiac reflex (OCR) | drop in heart rate below 60 bpm | 2 hours | |
Secondary | blood pressure | blood pressure in mmhg will be recorded preop, after induction, and every 15 minutes. | 2 hours | |
Secondary | heart rate | heart rate as beats per minute will be recorded preop, after induction, and every 15 minutes. | 2 hours |
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