The Effect of Rocuronium as an Anesthetic Adjuvant in Peribulbar Anesthesia for Adult Strabismus Surgery: Randomized Controlled Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- The duration of globe akinesia
研究概览
简要总结
- This is a prospective randomized clinical study that will be carried on adult patients aged from 21-60 years and presented for strabismus surgery under peribulbar anesthesia.
- Patients will be excluded if they refused to participate or had a contraindication to peribulbar anesthesia.
- Patients will be randomly distributed into either control group in which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline or rocuronium group which peribulbar anesthesia will be performed by injection of 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
- Measurements will include; -
- Patient age, weight, height, gestational age, and gravidity.
- The duration of globe akinesia (primary outcome).
- The onset of lid and globe akinesia and the duration of lid akinesia
- The onset and duration of sensory block
- Time required to start the surgery
- Akinesia score
- The visual analog score (VAS) which is composed of 0-10 score will be used to assess the severity of postoperative pain (where 0=no pain and 10=severe pain), The VAS score will be evaluated 1 h, 2 h postoperative, then every 2 h till 12 h. Any patients with VAS score more than 4 received rescue analgesia in the form of 50 mg tramadol intravenous injection with the calculation of the time for the first call of postoperative analgesia.
- Any detected complication as nausea and vomiting, pain on injection, or increased intraocular tension.
详细描述
This prospective randomized double-blind study will be carried out on adult patients who will be presented for strabismus surgery in Ophthalmology Department in Tanta university hospitals over the 6-month duration, an informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
The patients will be randomly allocated into two groups with the aid of computer-generated software of randomization. All the local anesthetic mixtures will be prepared under complete aseptic precautions by an anesthesia resident who will not participate in the study and will be blinded to its groups in to: - Group C (Control group) (20 Patients): Patients in this group will receive peribulbar anesthesia with a 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.
Group R (rocuronium group) (20 patients): Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
Anesthetic technique On arrival of patients to the pre-anesthesia preparation room, we will allow them to rest in a supine position with the connection of monitors that consist of 5 leads ECG, non-invasive blood pressure, pulse oximeter, and temperature. Also, intravascular access will be obtained.
Once the patient will be admitted to the operating theatre, all monitors will be applied. A nasal cannula was used at a flow rate of 2-4 l/min to supply oxygen to patients. The peribulbar block will be performed by the same anesthesiologist under aseptic precautions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- The patients will be blinded to their groups.
- An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions.
- The anesthetist who will perform the peribulbar block will be blinded to the local anesthetic mixtures he will inject.
- An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in a collection of the data of measurements
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •Aged 21- 60 years
- •American Society of Anesthesiologists class (ASA) I to III
- •presented for elective strabismus surgery under peribulbar anesthesia.
排除标准
- •Patient refusal to participate.
- •uncooperative patient.
- •Neurological disorders.
- •Psychological disorders
- •Suspected or diagnosed coagulopathy.
- •Known allergy to the used medications.
- •Ocular infection
- •Co-existing glaucoma
研究组 & 干预措施
Group C (Control group)
Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.
干预措施: Normal saline (Drug)
Group R (rocuronium group)
Patients in this group will receive peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
干预措施: Rocuronium (Drug)
结局指标
主要结局
The duration of globe akinesia
时间窗: up to first 2 hours intraoperative
Time interval from reaching the highest lid and globe akinesia score till restoration of the full lid and globe movement
次要结局
- The duration of sensory block(Intraoperative (Every 30 minutes in the first 4 hours))
- The onset of sensory block(Intraoperative (every 2 minutes after peribulbar injection))
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Assistant Professor
Tanta University