CTRI/2021/03/031837尚未招募不适用
PROSPECTIVE RANDOMIZED DOUBLE BLIND COMPARATIVE STUDY OF EVALUATING EFFICACY AND SAFETY OF TWO DIFFERENT DOSES OF FENTANYL FOR PREVENTION OF SYMPATHOMIMETIC RESPONSE TO LARYNGOSCOPY AND INTUBATION IN CONTROLLED HYPERTENSIVE PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Variation in heart rate, systolic blood pressure, diastolic blood pressure, ST-T changes, cardiac rhythm changes
研究概览
简要总结
- Laryngoscopy prior to intubation and intubation in itself produce significant hemodynamic stress response in the form of tachycardia and hypertensionwhich is usually transient, returns to base line within 10-15 minutes and well tolerated by healthy individuals without cardio-respiratory compromise but can prove disastrous in the patient with cardiac and neurological diseases.
- Among opioids, fentanyl citrate has been identified as a most effective agent for this purpose. Fentanyl is effective in blunting stress response to intubation and has been used for this purpose in different doses titrationranging from 1.5µg/kg to 6µg/kg in different studies.
- In most of the studies, investigators assessed response of fentanyl in normotensive population to prevent hemodynamic stress response to intubation. Their findings cannot be applied to the hypertensive population which behave quite differently than normotensive group.
- This prompted us to plan the present study to evaluate the efficacy and safety of two different doses of fentanyl (2µg and 3µg) to prevent hemodynamic stress response to laryngoscopy and intubation in controlled hypertensive patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed written consent.
- •Patients posted for elective surgery under general Anesthesia requiring endotracheal intubation.
- •ASA physical status || Well controlled primary idiopathic hypertension(blood pressure less then or equal to 140/90) with maximum three anti hypertensive medications excluding beta blockers.
- •No end organ involvement due to hypertension.
- •BMI less then or equal to
- •Modified Mallampati classification | and ||.
排除标准
- •Patient refusing for consent.
- •Patients with diabetes, COPD, renal disease, cardiac diseases like IHD, valvular heart disease, AV conduction block, aortic stenosis, left ventricular failure etc.
- •Patient on drugs(sedatives,opioids,anti-psychotic drugs and beta blockers).
- •Anticipated difficult intubation.
- •BMI more then or equal to
- •Intubation attempt lasting longer than 15 seconds.
- •Patient on more than 3 anti hypertensive medications.
- •Defaulter of taking anti hypertensive medications as per schedule.
结局指标
主要结局
Variation in heart rate, systolic blood pressure, diastolic blood pressure, ST-T changes, cardiac rhythm changes
时间窗: From injection of intravenous fentanyl to 20 minutes after endotracheal intubation
次要结局
- To asses sedative effect of fentanyl and to observe any complications(From injection of intravenous fentanyl to 60 minutes after endotracheal extubation)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A Study to compare the effect of three drugs -Dexmedetomidine, Lidocaine and Fentanyl in increasing heart rate and blood pressure in response to Laryngoscopy and Intubation in patients undergoing Cardiac SurgeryCTRI/2022/05/042885Department of Anaesthesiology90
尚未招募
不适用
Insertion of tube in the respiratory pathway using two different types of laryngoscope used for introductionCTRI/2020/11/029369Self funded60
尚未招募
不适用
Study to check the efficacy of Buprenorphine Patch 10mg in controlling the Blood Pressure and Heart Rate that increases in response to introduction of Laryngoscope and Endotracheal Tube into the airway in patients undergoing Surgery under General AnesthesiaCTRI/2022/09/045432Mahatma Gandhi University Of Medical Sciences And Technology60
进行中（未招募）
Phase 3 4
A study to compare nebulized fentanyl, dexmedetomedine and magnesium sulphate for attenuation of stress response to laryngoscopy and intubationCTRI/2021/09/036806esic medical college and hospitalfaridabad90
已完成
不适用
A Comparative Study of Glidescope Versus Macintosh Laryngoscope in Adult Hypertensive PatientsHypertensive PatientsNCT03316443Mansoura University90