Title: the Effects of Dexmedetomidine on Hemodynamic Responses to Endotracheal Intubation in Hypertensive Patients Undergoing Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Arterial Pressure (MAP)
研究概览
简要总结
Dexmedetomidine, an alpha-2 adrenergic agonist, has been shown to provide several benefits during endotracheal intubation:
- Reduced anxiety and stress: Dexmedetomidine's anxiolytic and sedative effects help reduce anxiety and stress associated with endotracheal intubation.
- Improved intubating conditions: Dexmedetomidine can improve intubating conditions by reducing the incidence of coughing, bucking, and laryngospasm.
- Decreased hemodynamic responses: Dexmedetomidine can attenuate the hemodynamic responses to intubation, including tachycardia, hypertension, and increased cardiac output.
- Increased ease of intubation: Dexmedetomidine can facilitate smoother and easier intubation by reducing the need for additional anesthetics or muscle relaxants.
The physiological responses to dexmedetomidine during intubation include:
- Decreased heart rate: Dexmedetomidine can cause a decrease in heart rate due to its effects on the sympathetic nervous system.
- Decreased blood pressure: Dexmedetomidine can also cause a decrease in blood pressure due to its vasodilatory effects.
- Increased sedation: Dexmedetomidine's sedative effects can help reduce anxiety and stress during intubation.
- Reduced respiratory rate: Dexmedetomidine can cause a decrease in respiratory rate due to its effects on the respiratory centers in the brain.
The clinical benefits of dexmedetomidine during intubation include:
- Improved patient comfort: Dexmedetomidine's sedative and anxiolytic effects can improve patient comfort during intubation.
- Reduced need for additional anesthetics: Dexmedetomidine can reduce the need for additional anesthetics or muscle relaxants during intubation.
- Decreased risk of complications: Dexmedetomidine's effects on hemodynamic responses and respiratory rate can decrease the risk of complications during intubation.
详细描述
General anesthesia during surgery produces a state of controlled unconsciousness during which the patient is unaware and insensitive to pain. Laryngoscopy and endotracheal intubation are mostly used to maintain airway while the patient is unconscious. Following the induction of anaesthesia, direct laryngoscopy and tracheal intubation are attributed to hemodynamic alterations brought on by sympathetic adrenergic outflow caused by laryngeal tissue stimulation, which may cause hypertension, tachycardia, arrhythmia, raised intracranial pressure, and intraocular pressure. The hemodynamic changes brought about by laryngoscopy and intubation were first described by Reid and Brace.This may be inconsequential in normal people but may lead to serious morbidity in patients with coexisting cerebrovascular or cardiovascular conditions.Patients undergoing treatment for hypertension have more pronounced hemodynamic responses to sympathetic stimulation.
Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with a distribution half-life of approximately 6 minutes frequently used in anesthesia practice. With only minimal respiratory depression and cardiovascular stability, dexmedetomidine produces sedation, hypnosis, analgesia, anxiolysis, and sympatholysis. The central effects are due to the activation of α-2A receptors in locus coeruleus, and cardiovascular effects are due to a dose-dependent decrease in the central sympathetic outflow. The transient hypertensive response is seen initially due to its effects on α-2B receptors present in the vascular smooth muscle until there is a decrease in the central sympathetic outflow.
The study's main aim is to assess the effectiveness of using dexmedetomidine as a preventative measure to lessen the sympathetic response caused by tracheal intubation in hypertensive individuals.
The objective of the study is to compare mean attenuation of stress response between groups given dexmedetomidine versus Normal Saline among hypertensive patients undergoing general anaesthesia with endotracheal intubation. We want to compare the effect of Dexmedetomidine on MAP at 5 minutes after laryngoscopy.
The study design is Prospective double blind Randomized Controlled Trial and will be conducted in Department of Anesthesia, Liaquat National hospital.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Grade II
- •Age > 60 years
- •Elective surgical procedures under GA.
- •All patients with a diagnosis of hypertension for 6 months or more and undergoing treatment with antihypertensive medications.
排除标准
- •Patient refusal
- •ASA Grade III and IV
- •Severely Hypovolemic state
- •Emergency surgeries
- •Body weight more than 20% of ideal body weight.
- •Patients with known or unanticipated difficult intubation and those requiring more than 15 sec or two attempts at laryngoscopy
- •Allergic to dexmedetomidine
- •Non complaint hypertensive patients
- •Patients with uncontrolled hypertension.
研究组 & 干预措施
Intervention group/Group D
Intervention group: Group D patients will be administer 0.5 mcg/kg dexmedetomidine intravenously over 10 min preoperatively.
干预措施: Dexmedetomidine Group / Group D (Drug)
Control group/Group C
Control group: Group C patients will be administer the same volume of normal saline (also intravenously for 10 min)
干预措施: Normal Saline (Placebo) (Other)
结局指标
主要结局
Mean Arterial Pressure (MAP)
时间窗: At 5 minutes after laryngoscopy and endotracheal intubation.
The primary outcome is to measure the change in Mean Arterial Pressure before endotracheal intubation and 5 minutes after intubation. An increase or decrease in MAP of 20 mmHg of patient's baseline MAP within 5 minutes of endotracheal intubation will be considered significant in our study. The focus is on whether Dexmedetomidine maintain MAP with 20mmhg of patient's baseline reading.
次要结局
- Heart Rate (HR)(Baseline & 5 minutes)
- Blood pressure (BP)(Baseline & 5 minutes)
研究者
Warisha Ismail
Warisha Ismail Dr, FCPS I
Liaquat National Hospital & Medical College