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临床试验/NCT06293586
NCT06293586招募中不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
The incidence of intraoperative oculocardiac reflex (OCR)

研究概览

简要总结

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.

详细描述

120 children, American Society of Anaesthesiology (ASA) I or II, aged 6 to 13 years, scheduled for elective squint surgery under GA will be included in the study. Children with tumors or infections of the orbit, raised intraocular pressure, eye injury, airway abnormalities or who are blind in the eye other than that which will to be operated, will be excluded. Other exclusion criteria will include known allergy to local anaesthetics or nonsteroidal anti-inflammatory drugs (NSAIDS), steroid therapy, those with significant cardiac, respiratory, renal, hepatic, or neurological disorders, mentally challenged children, or parental refusal to participate.

All children will undergo a detailed preanesthetic evaluation including previous history of operations, drug history, physical examination (cardiovascular and respiratory systems, blood pressure, oxygen saturation, airway and dentition, body weight and height). During the pre-anesthesia evaluation, children will be encouraged to report postoperative pain, if present. All children will be fasted for a minimum of 4 hours and premedicated with oral midazolam 0.5 mg/kg 30 minutes before anaesthesia. Anesthesia will be induced with sevoflurane 6% in oxygen or intravenous (i.v.) propofol (2mg/kg), as appropriate for the child's age and preference. Following inhalational induction, an intravenous line will be placed. The airway will be secured using an appropriately sized endotracheal tube (ETT) following intravenous atracurium(0.5 mg.kg) and 1 to 3 min of mask ventilation using isoflurane 1.5% in oxygen.Anesthesia will then be maintained with isoflurane in air-oxygen and end tidal minimal alveolar concentration maintained at 1 to 1.3. ventilation will be established at 6-8ml per kg with a target PECO2 of 32 - 34 and will be adjusted accordingly.

Children will then be randomly allocated to one of three groups; by a nurse who will not participate in the study, reads the number contained in the envelope and makes group assignment.

Children in the control group (group C, n_20) will receive IV paracetamol (20mg/kg).

Children in the sub-tenon group (sub-tenon group (S), n _ 20) will receive a sub-tenon block. Sub-Tenon's anesthesia will be performed with 5% bupivacaine (0.08 ml/kg). Under sterile conditions, a 19-gauge curved, blunt metallic cannula (25 mm) will be inserted into sub-Tenon's space and the local anesthetic will be injected by the ophthalmologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants were children (6-13 years), ASA I-II patients, scheduled to undergo strabismus surgery.

排除标准

  • 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.

研究组 & 干预措施

Peribulbar group (Group P)

Experimental

The peribulbar group (P group _ 40) received a peribulbar block with 0.25 mL/kg of a 1:1 local anesthetic mixture (LAM) of 0.5% bupivacaine and 2% lignocaine. Peribulbar block using a two-injection technique was performed by a second anesthetist under sterile conditions and before the application of surgical drapes. LAM was injected both infratemporal and superonasally using a 26-G needle, in contrast to the single infratemporal injection approach.

干预措施: peribulbar block (Procedure)

sub-tenon group (group S)

Experimental

Children in the sub-Tenon group (sub-Tenon group (S), n _ 40) received a sub-Tenon block. Sub-Tenon's anesthesia was performed with 0.5% bupivacaine (0.08 ml/kg), bearing in mind not to exceed the maximum dose. Under sterile conditions, a 19- gauge curved blunt metallic cannula (25 mm) was inserted into sub-Tenon's space and the local anesthetic was injected by the ophthalmologist after the application of surgical drapes.

干预措施: sub-tenon block (Procedure)

paracetamol (group C)

Active Comparator

Children in the paracetamol group received IV paracetamol (15 mg/kg) after induction of anesthesia before any surgical intervention.

干预措施: Paracetamol (Drug)

结局指标

主要结局

The incidence of intraoperative oculocardiac reflex (OCR)

时间窗: 2 hours

drop in heart rate below 60 bpm

次要结局

  • blood pressure(2 hours)
  • heart rate(2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Essam El-Din Zaki Bassyouni

assistant lecturer

Cairo University

研究点 (1)

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