CTRI/2023/12/060514尚未招募4 期
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. - Nil
Medical Research Unit of University College of Medical Sciences as an intramural grant0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 40-60. 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.
研究者
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