A Randomized Study To Compare The Hemodynamic Stress Response Between Conventional Awake Extubation Of Endotracheal Tube And I-GEL® Exchange Extubation During Emergence From General Anaesthesia In Craniotomy Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The change in Heart Rate,Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Blood Pressure.
研究概览
简要总结
This randomized comparative study aims to compare the hemodynamic stress response between conventional awake extubation of endotracheal tube (ETT) and I-gel® exchange extubation during emergence from general anesthesia in craniotomy surgeries. The study includes 70 patients undergoing elective craniotomy surgeries, divided into two groups: Group A (conventional awake endotracheal extubation, n=35) and Group B (extubation using Bailey’s maneuver over I-gel®, n=35). The study will be conducted at the department of Anesthesiology,
C. K. BIRLA Hospital, RBH, Jaipur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •With consent for the procedure, ASA grade 1 & 2,Age group 18 to 60 years,Modified Mallampati grade 1 and 2, Undergoing general anaesthesia for elective craniotomy surgeries,Tumor size less than 4cm,Aneurysm,Modified Fischer grade 1 or 2,Surgical duration less than 4 hours,Blood loss less than 400ml,Fasting greater than or equal to 8 hours,BMI less than 30.
排除标准
- •Refusal to give consent,History of allergic drug reaction to any of the proposed drugs set to be used during the procedure,Patients with anticipated difficult intubation,Glasgow coma score less than 15, ASA grade 3,4 and 5, Patients with signs of increased ICP Volumes greater than 1.5ml per kg on ultrasound guided gastric antrum examination, History of congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, acute respiratory distress syndrome, psychiatric illness, bleeding disorder, hepatic or renal dysfunction Patients who may need elective mechanical ventilation post operatively Patients who are receiving IV beta blockers Pregnancy.
结局指标
主要结局
The change in Heart Rate,Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Blood Pressure.
时间窗: The parametres were measured At the end of surgery, After reversal, 1 minute after reversal, 3 minutes after reversal, 5 minutes after reversal, 10 minutes after reversal, 15 minutes after reversal,1 hour post operatively and 6 hours post operatively.
次要结局
- To compare the total doses of intravenous Diltiazem required in each group to maintain hemodynamic parameters (Heart Rate & Mean Arterial Pressure) within 20% of baseline values during the extubation period.
研究者
DR Huda Subair
RUKMANI BIRLA HOSPITAL, A UNIT OF CMRI , JAIPUR