Comparison of three different doses of dexmedetomidine for attenuation of the pressor response to laryngoscopy and intubation by assessment of hemodynamic parameters and plasma catecholamine levels under Bi Spectral index guided anaesthesia - A prospective randomized controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- 1. To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, maintaining BIS values between 40-60.
研究概览
简要总结
Laryngoscopy and intubation are noxious stimuli which evoke a plethora of undesirable effects like tachycardia, hypertension and cardiac dysrhythmias with an increase in plasma catecholamine levels which can be life threatening for patients with underlying cardiac comorbidities.
Monitoring the depth of anaesthesia by Bi Spectral Index is vital in to prevent hypertension and tachycardia. A variety of pharmacological methods have been utilized for the attenuation of pressor response which include lignocaine, beta blockers, calcium channel blockers, opioids and dexmedetomidine.Dexmedetomidine has been compared with other agents in different doses ranging from 0.5μg/kg to 1μg/kgwith varied results.
In most of the studies on dexmedetomidine available in literature, the depth of anaesthesia and plasma catecholamine levels have never been studied in the context of obtaining an optimal dose.
Hence, this study will be planned using three different doses of dexmedtomidine namely 0.5 μg/kg, 0.75μg/kg, and 1 μg/kg in patients undergoing elective surgeries under general anaesthesia for attenuation of the pressor response by maintaining adequate depth of anaesthesia.
The primary objective will be to study and compare the change in heart rate and systolic blood pressure after administration of dexmedetomidine at different time intervals, maintaining adequate anaesthetic depth .
Also, to study and compare the change in plasma adrenaline and nor-adrenaline levels following administration of three different doses of dexmedetomidine prior to laryngoscopy and intubation.
This study will be carried out as a prospective, randomized**,** double blinded research projectafter approval by the Hospital Ethics committee, in 168 consenting adult patients aged 18-60 years of either sex, ASA Grade I & II undergoing elective surgery under general anesthesia with endotracheal intubation.
The patients will then be randomly distributed in one of the three study groups (50 patients each) by a computer generated random number table and allocation concealment will be performed by opaque sealed envelopes.
Group D1, Group D2 and Group D3 - Patients will be given IV Dexmedetomidine loading dose 0.5ug/kg, 0.75ug/kg and 1ug/kg diluted in normal saline up to 50 ml over 10 minutes prior to induction.
Expected Outcomes
To obtain the dose of dexmedetomidine which will effectively attenuate the pressor response, with confirmation by plasma catecholamine levels while maintaining adequate depth of anaesthesia and also avoiding the known side effects associated with a higher dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •All ASA I and II patients, aged 18-60 years, scheduled for elective surgery under general anesthesia.
- •In the preoperative area, an 18 G intravenous cannula will be inserted and venous blood sample for plasma adrenaline and nor-adrenaline will be drawn for the first time.
- •Subsequently, a ringer lactate drip at the rate of 8-10ml/kg per hour for all the study patients will be ensured.
- •On shifting the patient to the OR, all standard monitors including non invasive blood pressure (NIBP), oxygen saturation probe, electrocardiogram and BIS electrodes on the forehead will be applied.
- •The baseline parameters [Ta] including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), oxygen saturation (SPo2), BIS and MOAS will be recorded.
- •Subsequently infusion of the study drug, which will be prepared by an independent observer who will not be involved in the study will be initiated and continued as an infusion over 10 minutes.
- •During infusion of study drug if the oxygen saturation drops below 95%, then oxygen will be supplemented by a simple face mask at the rate of 5-6 litres/minute.
- •On completion of the study drug, all the parameters [Tb] will be recorded again and noted in the record sheet.
- •Anaesthesia will be induced with Inj Propofol 2mg/kg and Inj Fentanly 2ug/kg.
- •After, the loss of response to verbal commands (end point of induction), all the study parameters will be recorded [Tc] and BIS will be maintained between 40-60 with help of titration of propofol and inhalational agent sevoflurane.
- •The total dose of propofol required for induction shall be noted in all the study groups.
- •After checking the adequacy of mask ventilation, Inj Vecuronium bromide 0.1 mg/kg I/V will be administered and at the end of 3 minutes, just before performing laryngoscopy, all parameters [Td] will be noted.
- •A senior anesthesiologist will perform the laryngoscopy and intubation with an appropriate size endotracheal tube (ETT).
- •The study parameters will be recorded at 1 minute [Te], 2 minutes [Tf], 3 minutes [Tg], 5 minutes [Th] and 7 minutes [Ti] after intubation in all three study groups.
- •Anaesthesia will be maintained with oxygen: nitrous oxide in 50:50 % combination at flow of 2 litres per minute with sevoflurane and BIS will kept at all time intervals between 40-
- •At time Tg, the venous blood sample for plasma adrenaline and nor-adrenaline will also be drawn for a second time.
- •After the last recording of the study parameters, ie Ti the study will be complete.
排除标准
- •Patients with a history of pulmonary disease like COPD, asthma, pregnancy, morbid obesity, diabetes mellitus (HbA1c > 6.5%), uncontrolled hypertension, impaired kidney or liver function, progressive neurological disease and bleeding diathesis, anticipated difficult airway, time taken for laryngoscopy and intubation exceeding more than 15 seconds, more than one attempt made for laryngoscopy and endotracheal intubation will be excluded from this study.
结局指标
主要结局
1. To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, maintaining BIS values between 40-60.
时间窗: 1. To study and compare the change in heart rate and systolic blood pressure (SBP) after administration of dexmedetomidine in all the three groups at different time intervals, that is baseline, after completion of study drug, after induction, just before laryngoscopy, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation and 7 minutes after intubation, maintaining BIS values between 40-60.
次要结局
- 1. To study and compare the change in plasma adrenaline and nor-adrenaline levels following administration of three different doses of dexmedetomidine prior to laryngoscopy and intubation(2. To determine the change in the Modified Observer’s Assessment of Alertness/Sedation (MOAS) Scale recorded at baseline (before) the administration of dexmedetomidine and after its completion (10 minutes) in all the three study groups.)
研究者
Michell Gulabani
University College of Medical Sciences/Guru Tegh Bahadur Hospital