Comparative Study Between the Effect of Nasal Packing With Dexmedetomidine, Midazolam or Bupivacaine on Surgical Field Visualization During Functional Endoscopic Sinus Surgery .
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- We aim to assess the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in reducing bleeding during FESS operations in patients who require general anesthesia with endotracheal intubation.
研究概览
简要总结
The goal of this interventional study is to compare the nasal packing with dexmedetomidine .midazolam or bupivacaine on surgical field visualization during FESS . Study groups :
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
详细描述
This study will be conducted in Minia University Hospital This prospective randomized double-blind controlled clinical study will be conducted on 144 adult patients of both sexes, aged between 16 and 60 years old, with BMI up to 30 with ASA physical status I & II.
Parameters assessed:
- Intraoperative Monitoring:
- Surgical field visualization using the Boezaart scale.
- Hemodynamic changes among the study groups including the heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), and oxygen saturation (SPO2) measured at baseline, (10 min after packing), every 5 mins till the end of the surgery.
- Postoperative Evaluation
- Assess postoperative pain using VAS every 1 hour for the 1st six hours, every 2 hours for 12 hours then every 4 hours till 24 hours postoperatively.
- The sedation score will be assessed using the Ramsay sedation score as VAS intervals.
- Surgeon satisfaction will be assessed by a Likert scale.
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
- Double (Participant, Care Provider)
盲法说明
Group I (Group C): (control group) Patients in this group will receive only 5 ml of intranasal saline.
Group II (Group D): Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
Group III (Group M): Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.
Group IV (Group B): Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sexes
- •aged between 16 and 60 years old
- •with BMI up to 30
- •with ASA physical status I & II.
排除标准
- •Patients with a history of allergy to the study drugs.
- •Pregnant and lactating females.
- •Patients with severe liver, renal, or cardiac diseases
- •Patients with repeated nasal surgeries.
- •Patients with psychiatric conditions.
研究组 & 干预措施
Group I (Group C): (control group)
Patients in this group will receive only 5 ml of intranasal saline.
干预措施: Saline (Drug)
Group II (Group D)
Patients in this group will receive only intranasal Dexmedetomidine (1 mcg/kg) made up to 5 ml in normal saline.
干预措施: Dexmedetomidine (Drug)
Group III (Group M)
Patients in this group will receive only intranasal midazolam (0.2 mg/kg) made up to 5 ml in normal saline.
干预措施: Midazolam (Drug)
Group IV (Group B)
Patients in this group will receive only intranasal bupivacaine (0.5% solution) 5 ml.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
We aim to assess the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in reducing bleeding during FESS operations in patients who require general anesthesia with endotracheal intubation.
时间窗: Intraoperative (for 2 hours maximally)
Evaluate the efficacy of intranasal packing with dexmedetomidine, midazolam, or bupivacaine in improving surgical field visualization using the Boezaart Score. Grade Assessment 0 No bleeding (cadaveric conditions) 1. Slight bleeding, no suctioning required 2. Slight bleeding, occasional suctioning required 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible
次要结局
- Total requirement of nitroglycerine as a hypotensive agent.(postoperative (at the end of operation after 2 hours ))
- Comparing the surgeon satisfaction among the study groups.(Postoperative (immediately at the end of the surgery ))
- Hemodynamic changes among the study groups:(Intraoperative (baseline then every 5 minutes till the end of surgery ))
研究者
Fatma Rabea Mohammed
Lecturer
Minia University