Anesthesia for Upper Endoscopy and Colonoscopy in Cardiac Patients With Acute Anemia: Pretreatment With Low-dose Ketamine Can Reduce the Dose of Etomidate. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measurement of serum cortisl level
研究概览
简要总结
The aim of this study was to try to reduce the required dose of etomidate used in anesthesia for upper endoscopy and colonoscopy in critically ill cardiac patients who complain of severe anemia in cardiac intensive care units by using a low dose of ketamine, which helps to reduce the side effects of etomidate, the most important of which is its suppressive effect on the adrenal gland and the secretion of cortisol in such critical cases, while maintaining hemodynamic stability, and the patient's satisfaction.
详细描述
This Prospective Randomized Clinical Trial will be done in the period from November 2020 - October 2021, after approval of our local ethical committee, and based upon written informed consent, included sixty cardiac patients, ASA physical statuses III or IV, admitted in CCU and SICU, and scheduled for upper endoscopy together with colonoscopy for diagnosis and management of acute anemia.
The study will be performed in the CCU or SICU with the presence of all emergency equipment's. The gastroenterologist who performed the colonoscopies will be blinded from the type of drugs used for sedation.
All patients will receive a colonic preparation protocol before the operation, and bowel cleansing will be performed, and all patients will be fasting 8 hours before the procedures.
Anesthesia management:
After establishment of IV access, standard monitoring will be performed (noninvasive blood pressure, ECG, SpO2, and BIS using (Masimo) monitor).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All participants including care provider and outcome assessors will unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age 18 - 65 years,
- •ASA II-III
- •Ejection fraction (EF) > 30%.
排除标准
- •Poor left ventricular function (ejection fraction < 30%).
- •Recent myocardial infarction (last seven days),
- •Patients with uncontrolled chronic disease (uncontrolled diabetes mellitus (DM) and hypertension),
- •Known history of hypersensitivity to midazolam, fentanyl, etomidate, Or ketamine,
- •Severe respiratory, hepatic or renal failure,
- •History of neurological disorders or convulsions,
- •In addition, any need for further anesthetic drug administration other than the study protocol was another exclusion criterion of this study.
研究组 & 干预措施
Etomidate
Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.
干预措施: Etomidate (Drug)
Ketamine-Etomidate
Received Ketamine 0.5 mg/kg IV over 30 seconds then Etomidate 0.1 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.
干预措施: Ketamine Hydrochloride (Drug)
结局指标
主要结局
Measurement of serum cortisl level
时间窗: From preoperative baseline to post operative after 6 hours
Primary goal was to prove that if we combined etomidate with small dose of ketamine, the level of cortisol will be decreased to a lesser extent than in case we use etomidate alone. measurement will be done peoperative and 6 hours after the procedure
次要结局
- Incidence of perioperative cardiopulmonary complications(From preoperative till postoperative 6 hours)
- Level of pateint satisfaction(From preoperative till full recovery after 6 hours)
研究者
Mostafa Mohammed Elsaid Elhamamsy
Anesthesia Consultant
King Saud University