Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain Relieve
研究概览
简要总结
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc. Since all these drugs have certain limitations there was a search for more safe and effective drug
详细描述
Functional Endoscopic Sinus Surgery (FESS) is done via endoscope and the area is highly vascular thus it becomes important to minimize bleeding, hence we require hypotensive anesthesia.
Dexmedetomidine (a highly selective α2-receptor agonist that has sedative, analgesic, anxiolytic, and opioid sparing effects without significant respiratory depression) it also reduces the need for inhaled anesthetics. dexmedetomidine also minimizes postoperative opioid consumption as well as nausea, vomiting, and anxiety.
Melatonin is a neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. It possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin (available in 5mg tablet form) fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting.
Pregabalin, whose structure is similar to the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), possesses analgesic and anxiolytic activities and is effective in alleviating the neuropathic component of acute nociceptive pain of surgery. It has also been used as premedication to attenuate the hemodynamic stress response to laryngoscopy and intubation and to decrease intraoperative anesthetic requirement
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing Functional endoscopic sinus surgery (ASA I & II)
排除标准
- •Hepatic, renal, endocrinal, hematological disorders.
- •BMI>30 kg/m
- •Patients receiving magnesium supplementation, anticonvulsant drugs or antipsychotic drugs.
- •Chronic use of opioids.
- •Current treatment with β-blocker or calcium channel blocker.
- •Known allergies to any of study drugs.
- •Patients refusal to the study
研究组 & 干预措施
Dexmedetomidine Group
This Group about 30 patients will receive dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.2µg/kg/h throughout the surgery .
干预措施: Dexmedetomidine (Drug)
Melatonin Group
This Group about 30 patients will receive 10 mg melatonin (2 tablets) one hour before starting of the operation.
干预措施: Melatonin (Drug)
Pregabalin Group
This Group about 30 patients will receive oral pregabalin 150 mg one hour before starting of the operation..
干预措施: Pregabalin (Drug)
Control Group
This Group about 30 patients will receive oral starch tablet as a control. Heart rate (HR) and blood pressure values will be recorded at various intervals.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Relieve
时间窗: 2 hours post operative
Assessment of the pain post-operatively in patients with pain score by VAS as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain,
次要结局
- controlled blood pressure(From base line to 1 hour after the end of the operation)
- controlled pulse rate(From base line to 1 hour after the end of the operation)