A comparison of General Anesthesia Induction with Propofol versus Etomidate on blood glucose concentration in Diabetic and Non Diabetic patients during elective surgical procedure. A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- To compare the effect of induction doses of Propofol and Etomidate on Blood Glucose concentration in Diabetic and Non-Diabetic Patients during Elective Surgical Procedures
研究概览
简要总结
Background
Surgical stimulus is a noxious stimulus which produces various hemodynamic responses as well as alteration of blood glucose level. Acute hyperglycemia in the perioperative period is associated with significantly increased morbidity, complications and worsens prognosis even in the patients who had normal glucose tolerance test. Despite a multitude of observation, varying opinions are available regarding hypergylcemia response of anesthetic agents and techniques.Both Propofol and Etomidate have similar mechanism of action but may not have similar effects on the body in response to surgical stress.A comparison between these induction agents and the effect they have blood glucose can greatly affect intraoperative management of diabetic patients.
Objective and need for study
To compare the effect of induction doses of Propofol and Etomidate on Blood Glucose concentration in Diabetic and Non-Diabetic Patients during Elective Surgical Procedures.
Methodology
Subjects will be randomly assigned to one of two groups .Each group will consist of 80 participants, equally divided into 40 diabetic and 40 non-diabetic patients.NPO status and Consent will be confirmed on the morning of the surgery. Vital parameters Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Oxygen Saturation (SpO2) and will be monitored and baseline recordings will be noted. Preinduction General Random Blood Sugar(GRBS) will be documented with a glucometer. Patients will be preoxygenated and premedicated prior to induction. Induction done with either Injection Propofol 2mg/kg or Injection Etomidate 0.3mg/kg . GRBS will be measured using Glucometer at 5 minutes , 15 minutes and 30 minutes after induction. 25g of glucose or dextrose is used for treatment of intraoperative hypoglycemia for blood glucose less than 80mg/dL as per institutional protocols. Hyperglycemia more than 180mg/dL will be treated with sliding scale regiment starting with 4IU for GRBS of 180 to 220 and an increase of 2IU for every 40mg/dL increase in GRBS. Haemodynamic Parameters HR, SBP, DBP, MAP, SpO2, and End Tidal Carbon Dioxide (ETCO2) will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists class 1 and 2 which include Non diabetic and controlled diabetic individuals
- •Patients scheduled for elective surgeries under General Anesthesia.
排除标准
- •1.Individuals with associated comorbidities like Hypertension on Alpha or Beta Blockers 2.Difficult Airway 3.Emergency and Laparoscopic Surgeries 4.Sevoflurane Induction 5.Patients on any medications that alter blood glucose levels such as steroids.
- •6.Patients with Psychiatric Illness 7.Patients with allergy to Study Drugs.
- •8.Obese patients with a Body Mass Index of more than 30 percentage.
结局指标
主要结局
To compare the effect of induction doses of Propofol and Etomidate on Blood Glucose concentration in Diabetic and Non-Diabetic Patients during Elective Surgical Procedures
时间窗: Blood glucose will be monitored prior to general anesthesia induction and then at 5, 15 and 30 minutes respectively.
次要结局
- 1.To assess Haemodynamic response to induction doses of Propofol and Etomidate(2.To ascertain for any correlation between blood sugar and hemodynamic parameters on Induction with Propofol and Etomidate)
研究者
Rachel Mary Louis
St Johns Medical College Hospital