Dexmedetomidine Different Doses as Adjuvant to Entropy-assisted General Anesthesia During Functional Endoscopy Sinus Surgery. A Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Surgical field quality using Fromme et al 6-point bleeding scale
研究概览
简要总结
The aim of work to assess the effect of different doses of Dexmedetomidine when used as an adjuvant to entropy-guided general anesthesia on the intraoperative surgical field quality, inhaled anesthesia consumption and postoperative analgesia requirement during FESS surgeries.
详细描述
This randomized comparative study is designed to:
- To assess between the effect of different dose Dexmedetomidine infusions on the surgical field quality.
- To determine the effect of different dose of Dexmedetomidine infusions on the required MAC of isoflurane needed to maintain entropy between 40-60.
- To determine the effect of different of Dexmedetomidine on the patient recovery time, and the postoperative analgesic requirement.
Hypothesis
The primary objective of this study is to find out the optimum infusion dose of Dexmedetomidine for the best surgical field quality, reduces inhalational anesthetic requirement without affecting recovery time.
On arrival to the operating room, an 18G cannula will be inserted and 500 ml Ringer acetate solution will be started slowly. Standard monitoring (electrocardiography, pulse oximetry and non-invasive blood pressure monitoring) will be connected to the patient, baseline blood pressure and heart rate will be measured and recorded. The 3-electrode sensor of the entropy (GE carestation 650) will be applied to the patient's forehead and the baseline state entropy (SE) and response entropy (RE) will be recorded. The patient will be premedicated with intravenous Ranitidine 50 mg and Metoclopramide 10 mg. Patients will be equally divided into three equal groups and will be given the following according to group allotted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •American Society of Anesthesiology (ASA) Class I or II undergoing elective functional endoscopic sinus surgery.
排除标准
- •American Society of Anaesthesiology (ASA) Class ≥ III
- •Allergy or hypersensitivity to Dexamedetomidine.
- •History of myocardial dysfunction.
- •Cardiac dysrhythmia and Heart block
- •Patients receiving beta blockers or calcium channel blockers
- •Patient refusal
- •Patient with known history of hepatic or renal disease
研究组 & 干预措施
G0.2
(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.2 mcg/kg/hour
干预措施: Dexmedetomidine (Drug)
G0.4
(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.4 mcg/kg/hour
干预措施: Dexmedetomidine (Drug)
G0.6
(33) patients will receive after induction of anesthesia DEX at 1 mcg/kg for 10 minutes followed by infusion at the rate of 0.6 mcg/kg/hour
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Surgical field quality using Fromme et al 6-point bleeding scale
时间窗: Through operative time, an average of 1 to 2 hours
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 surgical field a few seconds after suction is removed 4. Moderate bleeding - frequent suctioning required and bleeding threatens 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 compromised
次要结局
- Postoperative Sedation Score(Two hours)
- Intraoperative hemodynamics including HR ( beats/min.)(Through operative time, an average of 1 to 2 hours)
- Intraoperative hemodynamics including MAP (mmHg)(Through operative time, an average of 1 to 2 hours)
- End tidal isoflurane concentration needed to maintain SE 40-60(Through operative time, an average of 1 to 2 hours)
- Postoperative Pain Score(Two hours)
- End tidal isoflurane concentration needed to maintain RE 40-60(Through operative time, an average of 1 to 2 hours)
- The duration of anesthesia and recovery time(Through operative and recovery time, an average of 3 to 4 hours)
- Immediate postoperative pethidine consumption (mg) in PACU(Two hours)
研究者
Mohamed Ahmed Mohamed Youssef Ollaek
Lecturer
Cairo University