A Prospective Randomized Comparative Study of Glidescope Versus Macintosh Laryngoscope in Adult Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Arterial blood pressure changes
研究概览
简要总结
Hemodynamic response to laryngoscopy and tracheal intubation remain of utmost concern in anesthesia practice. Sympathetic stimulation and adverse physiologic events could be tolerated by healthy individuals, but they may be detrimental in hypertensive patients.
The magnitude of hemodynamic response of intubation is related to the degree of manipulation of the oropharyngeo-laryngeal structures. Unlike Macintosh laryngoscope,Glidescope is a device that does not require alignment of oropharyngeal axis to visualize the glottis.It needs less upward lifting force with less manipulation of pharyngeal structures during the intubation.
It was reported that Glidescope had no significant advantage over Macintosh in attenuating circulatory response to endotracheal intubation in normotensive patients.Till now no clinical trials investigate the hemodynamic effects of Glidescope in hypertensive patients.The investigators hypothesized that the Glidescope will induce less hemodynamic changes among hypertensive patients during endotracheal intubation.So the study was designed to compare effects of Glidescope versus Macintosh laryngoscope in hypertensive patients with special regard to hemodynamics and intubation conditions.
详细描述
This is prospective randomized study will performed at Urology and Nephrology Centre, Mansoura University after approval from Institutional Research Board, Mansoura University.Patients were interviewed and written informed consent will be obtained from selected patients scheduled for different urological surgeries.
Eligible adult patients will be randomly allocated by a computer-generated randomization sequence into 2 equal groups:
Macintosh group: 45 patients will be intubated by Macintosh laryngoscope(Group M).
Glidescope group: 45 patients will be intubated by Glidescope(Group G).
Preoperative assessment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 20 year old.
- •Patients classified by the American society of anesthesiologist as 2 or 3 with controlled hypertension.
- •Patients with body mass index less than
- •Mallampati score 1 or 2, thyromental distance more than 4 cm and central incisor interdistance more than 3 cm will included.
排除标准
- •Patient refusal.
- •Patient with uncontrolled hypertension (patients diagnosed as uncontrolled hypertension if they have history of hypertension and systolic blood pressure after 3 measures after admission exceeding 150 mmHg despite of regular antihypertensive therapy).
- •Patient with major cardiac diseases (e.g cardiomyopathy).
- •Patient with cerebrovascular accidents.
- •Patient with history of difficult intubation.
- •Patients at risk of aspiration who require rapid sequence induction.
研究组 & 干预措施
(Group G)
Glidescope group: 45 patients will be intubated by Glidescope (Group G). For endotracheal intubation with glidoscope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator.
干预措施: Glidescope (Device)
(Group M)
Macintosh group: 45 patients will be intubated by Macintosh laryngoscope (Group M).The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first, the laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced
干预措施: Macintosh (Device)
结局指标
主要结局
Arterial blood pressure changes
时间窗: During 10 minutes of trial of endotracheal intubation.
Mean arterial blood pressure changes with the use of each device for endotracheal intubation.
Heart rate changes
时间窗: During 10 minutes of trial of endotracheal intubation.
Heart rate changes with the use of each device for endotracheal intubation.
Arterial blood pressure changes
时间窗: During 10 minutes after endotracheal inubation.
Systolic arterial blood pressure changes with the use of each device for endotracheal intubation.
Arterial blood pressure changes
时间窗: During 10 minutes after endotracheal intubation.
Diastolic arterial blood pressure changes with the use of each device for endotracheal intubation.
次要结局
- Success rate of endotracheal intubation with each device.(During intraoperative trial of endotracheal intubation.)
- Endotracheal intubation time with each device.(During intraoperative trials of endotracheal intubation.)
- Attempts of endotracheal intubation with each device.(During intraoperative trials of endotracheal intubation.)
- severity of sore throat with each device.(24 hours after endotracheal intubation)
- severity of hoarseness of voice with each device.(24 hours after endotracheal intubation)
研究者
Mahmoud Mahmoud Othman
professor of Anesthesia and surgical ICU
Mansoura University