Intrathecal Fentanyl and Dexmedetomidine Added to Bupivacaine for Subarachnoid Anaesthesia for Percutaneous Nephrolithotomy: A Randomized Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to evaluate the sedation grade
研究概览
简要总结
Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block.Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics. According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects.The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia.
详细描述
Spinal anesthesia is a straightforward procedure that acts quickly. However, because of its neurotoxic effects, a common anesthetic like lidocaine has mostly been substituted by alternative substances like bupivacaine. Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block. Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics.
The danger of respiratory depression for lipophilic opioids, such as fentanyl and sufentanil, is primarily restricted to the first two hours following intrathecal injection. Because fentanyl is more lipid soluble than morphine, there is a significantly lower chance of delayed respiratory depression brought on by the rostral distribution of an intrathecal injected drug to respiratory centers.
Both visceral and somatic pain can be reduced by intrathecal α2 receptor agonists. Compared to clonidine (α2/α1 200:1), dexmedetomidine has greater selectivity for the α2 receptor (α2/α1 1600:1). According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects. The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia.
.
Methods and patients:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sex aged between 18 and 60 years,
- •belonging to American Society of Anaesthesiologists (ASA) physical status Grade I and II undergoing PCNL under spinal anaesthesia.
排除标准
- •Patients with a history of spine surgery,
- •infection at the injection site,
- •coagulopathy,
- •hypovolemia,
- •increased intracranial pressure,
- •indeterminate neurologic disease,
- •spinal deformities,
- •communication problems,
- •known hypersensitivity to local anaesthetics, opioids or dexmedetomidine
研究组 & 干预措施
Group fentanyl (F)
an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be given intrathecal
干预措施: Intrathecal Fentanyl Group (F) (Procedure)
Group dexmedetomidine( D)
In Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel.
干预措施: intrathecal dexmedetomidine group(D) (Procedure)
结局指标
主要结局
to evaluate the sedation grade
时间窗: 10 minutes after giving the intervention , then after 30 minutes , then at the end of the surgery (assessed up to 40 minutes)
5- Ramsay Sedation Score 1. \- Anxious, agitated/restless or both 2. \- Patient cooperative, oriented, and tranquil 3. \- Patient responds to commands only 4. \- Brisk response to a light glabellar tap or loud auditory stimulus 5. \- Sluggish response to light glabellar tap or loud auditory stimulus 6. \- Patient shows no response.
to evaluate patient satisfaction
时间窗: at the end of the surgery (assessed up to 40 minutes)
The level of patient's satisfaction was measured using five-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)
次要结局
- to record Post-operative and intraoperative complications(during the procedure ,24 hour postoperatively)
- to compare the onset,duration of motor blockade between the two groups(Motor power assessment was done every five minutes, for 30 min after spinal anesthesia, and then every 20 min until the end of surgery. The time to achieve Bromage 3 was considered an onset of the motor block. Duration of motor block was considered until)
- to compare analgesia onset, duration ,peak sensory level(after giving the intervention every 1 minutes till reach level T6 (assessed up to 10 minutes))
- to compare the initial post-operative analgesia request(24 hour after surgery)
- to compare the mean arterial blood pressure between the two groups(every 5 min up to 15 min after the intervention , then every 15 min during surgery and then for each hour after surgery in the ward(up to 4 hour).)
- to compare heart rate between to groups(every 5 min up to 15 min after the intervention , then every 15 min during surgery and then for each hour after surgery in the ward(up to 4 hour))