Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block for Various Anal Surgeries: A Correlative Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- the duration until the first call for analgesia
研究概览
简要总结
Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.
详细描述
Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor blocks in both limbs.
Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward and PACU was determined utilizing the visual analog scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
盲法说明
The subjects were randomly categorized into two groups utilizing random numbers generated by computer software. A sealed envelope (containing the allocation numbers of groups) was opened at the time of patient enrollment.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both sexes
- •aged between 20 and 60
- •classified as II & ASA-I
- •scheduled for elective anal surgeries
排除标准
- •subjects who refused to participate
- •uncontrolled hypertension
- •BMI > 30 kg/m2
- •heart failure (class IV or III) based on the New York Heart Association (NYHA)
- •uncorrected coagulopathy
- •any study's drug allergy
- •drug abuse
- •neuropathy
- •any spinal anesthesia contraindication (such as infection or a pelvic fracture)
研究组 & 干预措施
The FENT Group
Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).
干预措施: FENT group (Drug)
The DEX Group
The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
干预措施: DEX group (Drug)
结局指标
主要结局
the duration until the first call for analgesia
时间窗: 20 months
the duration until the first call for analgesia
次要结局
- the duration from spinal injection until reaching the maximal sensory level(20 months)
- the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level(20 months)
- the time required for sensory regression until reaching the S1 level (from the maximal sensory level)(20 months)
- the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)(20 months)
- side effects occurrences(20 months)