Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Blood Loss
研究概览
简要总结
the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate .
A prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):-
- Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia.
- Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia.
- Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.
详细描述
Hypothesis:
Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via optimization of blood pressure and heart rate.
Objectives Compare the effect of preoperative Gabapentin with Bisoprolol on hemodynamics, surgical field optimization during endoscopic nasal surgeries.
Technical design:
A) Site of study :
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)
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
- •patients who underwent functional endoscopic sinus surgery
- •ability to swallow tablets
排除标准
- •suspected difficult airway
- •basal HR <60/min.
- •chronic cardiovascular or cerebrovascular disease
- •bronchial asthma or COPD
- •bleeding disorders
- •anemia (Hb level< 10 gm/dl)
- •renal or hepatic insufficiency
- •psychiatric disorders
- •chronic treatment by BBs, gabapentin or drugs that affect coagulation
- •acute nasal infection
- •allergy/contraindications to any of the study's drugs.
研究组 & 干预措施
gabapentin
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
干预措施: Gabapentin1200 mg (Drug)
bisoprolol
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
干预措施: bisoprolol 2.5mg (Drug)
control
placebo was given to patients of control group 2 hours preoperative
干预措施: placebo (Drug)
结局指标
主要结局
Blood Loss
时间窗: at the end of surgery
total intraoperative blood loss (mL)
Changes in Surgical Field Visibility
时间窗: scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end
according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding. 1. Slight bleeding- no blood suctioning required. 2. Slight bleeding- occasional blood suctioning required. 3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation. 4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation. 5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.
次要结局
- Mean Arterial Blood Pressure Change(were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery)
- Heart Rate Change(were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery)
研究者
abeer M. elnakera
assistant professor of anesthesia and surgical intensive care
Zagazig University