Fentanyl Versus Dexmedetomidine As an Adjuvant to Bupivacaine in Spinal Anaesthesia for Appendectomy Patients; Peritoneal Symptomatic Effects: a Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- intraoperative peritoneal symptoms during appendectomy.
研究概览
简要总结
To compare whether 5 μg dexmedetomidine with 25 μg fentanyl added to 0.5% hyperbaric bupivacaine as adjuvants in spinal anaesthesia in patients undergoing appendectomy could reduce intraoperative peritoneal related symptoms.
详细描述
Acute appendicitis is among the most common causes of lower abdominal pain leading patients to attend the emergency department and the most common diagnosis made in young patients admitted to the hospital with an acute abdomen .
In intracavitary abdominal surgery (e.g. Appendectomy),general anesthesia is conventionally chosen as it provides a higher safety profile with respect to the risk of aspiration, abdominal discomfort, and better exposure secondary to muscle relaxation however, at present it is considered safe to do spinal anesthesia in various abdominal procedures, even where significant muscle relaxation is required in certain complex cases such as peritonitis many patients with complicated conditions were operated under spinal anesthesia, which did not significantly interfere with surgical technique or exposure. Additional advantages of spinal anesthesia include faster recovery, better oral tolerance, and shorter hospital stay compared to general anesthesia.
The Covid-19 pandemic currently affects almost every aspect of healthcare. The risk to the operating room team from the contaminated aerosols produced by intubation and positive pressure ventilation may be reduced by performing suitable open operations with neuraxial anaesthesia instead of General anesthesia .
Neuroaxial anesthesia is commonly preferred for surgeries of lower abdomen, perineal and lower limb. It is easy to administer and very economical but needs skills. Intrathecal local anesthetics are limited by short duration of action and needs early use of rescue analgesia postoperatively. Adjuvants are added to improve quality and duration, provide better postoperative analgesia and patient comfort.
A common problem during abdominal surgeries under spinal anesthesia is peritoneal related symptoms as visceral pain, nausea, vomiting, vagal symptoms like bradycardia and hypotension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
concealed based on study drugs assigned to each group & to conduct this double -blinded clinical trials, our study drugs will be prepared by the senior anesthesiologist who won't be involved in further observations of the patients and neither patients nor outcome assessor will be aware of which drugs they will receive.
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
- •ASA physical status class I and II.
- •Age between 18 - 60 years of either sex.
排除标准
- •ASA grade III and IV.
- •Infection at the site of injection.
- •Coagulopathy or anticoagulation.
- •Congenital anomalies of lower spine.
- •Active disease of CNS.
- •History of allergy to local anesthetics or the adjuvants.
- •Complicated appendicitis.
研究组 & 干预措施
Group D (N.74)
5µg Dexmedetomidine {precedexTM 200U/2ml Hospira, Inc,lake forest,iL,USA} (5 µg added by taking 50 µg in a insulin syringe) + 4ml 0.5% heavy bupivacaine HCl.
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Group F (N.74) -
25 µg Fentanyl {fentanyl Hameln 50 u/ml Gmbh-germany} + 4ml 0.5% heavy bupivacaine HCl.
干预措施: Fentanyl HCl (Drug)
结局指标
主要结局
intraoperative peritoneal symptoms during appendectomy.
时间窗: Intraoperative period in minutes
Compare between the efficacy of dexmedetomidine and fentanyl as adjuvants on decreasing the intraoperative peritoneal symptoms such as abdominal discomfort or visceral pain, nausea and vomiting, vagal symptoms like bradycardia and hypotension during appendectomy.
次要结局
- Assessment of motor block with Modified Bromage scale(1,6,12,18 and 24 hours)
- Degree of post-operative analgesia(1,6,12,18 and 24 hours)
- Assessment of sensory block by using pin prick method(Time in minutes)
研究者
Soudy Salah Hammad
Lecturer of anesthesia and surgical intensive care
Aswan University