A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
试验速览
- 阶段
- 不适用
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The safety of anesthetist administered sedation (AAS) with general anesthesia for ERCP.
研究概览
简要总结
Currently there no standard sedation techniques for performing ERCP. It is not clear whether sedation administered by anesthetist is better than anesthesia with intratracheal intubation. To clarify which of these sedative methods are better we plan to conduct a randomized trial comparing anesthetist administered sedation with general anesthesia in patients with ASA ≤3.
详细描述
ERCP is a relatively complex and lengthy endoscopic procedure. It is increasingly performed in elderly patients with multiple comorbidities and carries serious complications including death in about 0.33% of patients. An important aspect of endoscopy is sedation. The role of sedation is to make the procedure tolerable and acceptable to the patient by reducing anxiety and discomfort. It ensures that the patient is relatively still to avoid injury and enhance the chances of an efficient and successful procedure. Hence, adequate and appropriate sedation is of utmost importance to maximize patient comfort and minimize adverse events in ERCP.
The debate between anesthetist and gastroenterologist continues, as there is dearth of evidence evaluating the best form of sedative technique for ERCP.
Three prospective studies have tried to compare AAS with general anesthesia. Despite the fact that significantly more patients who had a higher body mass index (BMI) and were of ASA class 3 and above in the general anesthesia group, hypoxic events of less than 84% were much more common in patients having AAS then those who had general anesthesia (15% in AAS vs 6.7% in general anesthesia). On the other hand, hypotension (34% in general anesthesia vs 4% in AAS,) and arrhythmias (8% in general anesthesia vs 3% in AAS) were much more frequent in general anesthesia group than AAS. Upto 4% of patients had to be converted to general anesthesia due to cardiopulmonary compromise. However, the conclusion drawn was that AAS is as safe and effective as general anesthesia. Major caveats bring into question the conclusion. The studies were observational and non-randomized which introduces selection bias.
A recent randomized controlled trail that looked at general anesthesia versu AAS during ERCP concluded general anesthesia had a better safety profile than AAS (17). However, this study included only patient who were high risk for sedation related adverse events with ASA class >3 and the anesthesia was provided by nurse anesthetist. Hence, these results cannot be generalized. There are no randomized trials comparing AAS with general anesthesia in patients with ASA ≤3, which includes the vast majority of patients having ERCP
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Referred for ERCP
- •Assessed by anesthetist
排除标准
- •Emergency situation (upper GI bleed, on mechanical ventilation)
- •ASA class ≥4
- •Distorted anatomy - like partial or total gastrectomy
- •Pregnancy
- •Unable to give or obtain consent and/ or disturbed level of consciousness
- •Suspected difficult intubation using Ganzouri score > than 5 (18).
- •Allergy to any study medication.
结局指标
主要结局
The safety of anesthetist administered sedation (AAS) with general anesthesia for ERCP.
时间窗: 2 years
Significant cardiopulmonary complications will be defined as 1) Hypotension - when systolic BP drops below 25% of the baseline measurement requiring vasopressor drugs; 2) Cardiac Arrythmia - Bradycardia when heart rate drops below 50 beats/min or rises above 120 beats/min requiring treatment; 3) Hypoxia - when oxygen saturation falls below 90%; 4) Hypercapnia - when expiratory carbon dioxide increase by more than 25% from the baseline; 5) Apnea when respiratory activity ceases for ≥10 seconds via capnography; 6) Any interruption or termination of ERCP procedure related to sedation
次要结局
- -The patient and endoscopist satisfaction with both types of sedation -The recovery time of AAS and general anesthesia(2 years)