Effect of Scalp Blocks on Postoperative Nausea & Vomiting & Recovery Profiles After Craniotomy: A Randomized, Double-Blind, and Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PONV incidence & severity during the 1st 24 hours in ICU.
研究概览
简要总结
In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time
详细描述
Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study
Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I and II patients,
- •aged 18 to 50 years,
- •70-80 kg,
- •undergoing elective supratentorial craniotomy
排除标准
- •patients under 18 years of age,
- •pregnancy,
- •emergency surgery,
- •patients with a Glasgow Coma Score (GCS) less than 15,
- •those with documented allergy to bupivacaine,
- •regular communication not possible,
- •Patients requiring prolonged mechanical ventilation (> 2 hours after end of surgery) will be also excluded
结局指标
主要结局
PONV incidence & severity during the 1st 24 hours in ICU.
时间窗: 24 hours
The intensity of the PONV was classified as: 0: without PONV, 1: nausea, 2: vomiting and 3: vomiting more than 2 times \[8\]. In addition, the incidence of PONV, the first time there was need for ondansetron and its total dose was recorded. With PONV score ≥ 2, the investigators used 4 mg ondansetron IV for antiemetic regimen. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
次要结局
- Total intraoperative fentanyl consumption in microgram(6 hours)
- Recovery time in minutes(10 minutes)
- Intraoperative Mean blood pressure in mmHg(6 hours)
- Intraoperative Heart rate as number of beats per minute(6 hours)
研究者
Raham Hasan Mostafa, MD
Assistant Professor of Anesthesia
Ain Shams University