A Comparative Study on Three Different Doses of Intrathecal Hyperbaric Prilocaine With Fentanyl for Optimal Dose to be Used in Elderly Patients Undergoing Day Case Lower Abdominal and Urologic Surgeries.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Duration of motor Block in hours
研究概览
简要总结
To compare the effects of using different doses of intrathecal hyperbaric prilocaine 2% combined with fentanyl 25 µg in patients scheduled for a day-case lower abdominal and urologic surgery in the geriatric patient population.
详细描述
- To evaluate the safety and effectiveness of spinal anaesthesia with hyperbaric Prilocaine 2% in a reduced dose (30mg) in combination with Fentanyl (25µg) in day-case lower abdominal and urologic surgeries in the geriatric population.
- To compare between three different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
- To estimate the duration of stay in PACU and hospital stay with different doses of prilocaine 2% in elderly patients undergoing day case lower abdominal and urologic surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Patients will be randomly allocated to one of the 3 groups by sealed closed envelop technique
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (65 - 80)
- •ASA I - III
- •Both genders.
- •Height (1.60-1.90) m.
- •BMI (18.5-40) kg m-2
- •Scheduled for elective day-case lower abdominal or urologic procedures < 90 minutes in duration under spinal anesthesia.
- •Type of surgery: Inguinal, femoral and incisional herniorrhaphies, bilateral varicocelectomies, hydrocelectomy, lymph node biopsies and mass excision biopsies, TURP surgery, Cystoscopies, ureteroscopy, bladder stone extraction, DJ insertion.
排除标准
- •Patients requiring general anesthesia.
- •Operations requiring sensory block above T
- •Known or suspected coagulopathy (international normalised ratio > 1.4), thrombocytopenia (platelet count < 100,000).
- •Known peripheral neuropathy, neurological deficits or skeletal deformities.
- •Known allergy to prilocaine.
- •Infection at site of injection.
- •Patients' refusal to sign informed consent.
- •Patients 'not meet inclusion criteria.
研究组 & 干预措施
● Group P1 (N 15)
Patients assigned to this group will receive intrathecal 30 mg (1.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
干预措施: Pilocaine 2% (1.5 ml) and 25 ug fentany (Drug)
● Group P2 (N 15)
Patient assigned to this group will receive intrathecal 40 mg (2 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml).
干预措施: Pilocaine 2% (1.5 ml) and 25 ug fentany (Drug)
● Group P3 (N 15)
patient assigned to this group will receive intrathecal 50 mg (2.5 ml) of prilocaine 2% + 25 ug fentanyl (0.5 ml)
干预措施: Pilocaine 2% (1.5 ml) and 25 ug fentany (Drug)
结局指标
主要结局
Duration of motor Block in hours
时间窗: Through Study Completion,an average of 1day
The primary outcome measure will be duration of motor Block in minutes, defined as the duration between intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block).
次要结局
- Onset of motor block in minutes(Through Study Completion,an average of 1day)
- Highest dermatomal level of sensory block.(Through Study Completion,an average of 1day)
- Onset of sensory block in minutes(Through Study Completion,an average of 1day)
- Motor block at the time of reaching highest sensory block.(through study completion,an average of 1day)
- Full regression of sensory block(Through Study Completion,an average of 1day)
- Duration of PACU stay(Through Study Completion,an average of 1day)
- Time to reach to highest sensory block in minutes.(Through study completion,an average of 1day)
- The incidence of adverse effects(Through Study Completion,an average of 1day)
研究者
Ahmed Abdalla
Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University