A Randomized Controlled Trial (RCT) of Efficacy and Safety of Sedation Compared to General Anesthesia for Endoscopic Retrograde Cholangio-pancreatography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ERCP success rate
研究概览
简要总结
There is a worldwide trend to minimally invasive interventions, which results in increasing numbers of interventions performed outside of the operating room. Currently, approximately 12 to 15% of total anaesthetic workload is non-operating room anaesthesia (NORA) and this anaesthetic activity is increasing.
Many of these interventions need supplementary comfort measures to have relaxed patients and high success rates. Endoscopic retrograde cholangio-pancreatography (ERCP) is performed >50,000 times per year in the U.S.,and is a typical minimally invasive intervention that needs patient sedation.
There is a controversy about the optimal comfort intervention in minimally invasive interventions and in particular in ERCP. Two different approaches to insure patients' comfort have been proposed: general anaesthesia with endotracheal intubation and mechanical ventilation or sedation with spontaneous ventilation.
Well-performed studies on sedation versus general anaesthesia using a randomized controlled trial design with observer blinding will contribute to improve the decision-making for the optimal comfort measures in minimally invasive procedures. At our knowledge such a randomized controlled trial has not been reported before. The investigators hypothesize that deep sedation without tracheal intubation will achieve similar success rates for ERCP as general anaesthesia and will have similar rates of harmful postoperative effects.
The primary aim of this trial is to demonstrate that the success rate of ERCP is not inferior in patients randomized to deep sedation without orotracheal intubation vs general anesthesia with orotracheal intubation. Secondary aims include a comparison between randomization groups of patient safety, patient and endoscopist satisfaction, duration of patient recovery and of anesthesia procedure.
详细描述
What may be the benefits of general anaesthesia? In one retrospective study of more than 1000 patients, the ERCP failure rate with general anaesthesia was half compared to that observed with moderate sedation (7% versus 14%), with most failures resulting from inadequate sedation. It has also been reported that complication rates associated with therapeutic interventions during ERCP may be significantly lower when general anaesthesia is used, perhaps because the absence of patient movement makes the procedure technically less difficult. When general anaesthesia is administered for ERCP, the airway is protected by endotracheal intubation which may decrease risk for broncho-aspiration in some patients, although this measure has not been demonstrated to be effective in patients at risk during digestive endoscopy.
However, aspiration at the time of in/ex-tubation as well as micro-aspiration of contaminated upper airway secretions along leaks and defects of the tracheal cuff seal is not excluded if standard endotracheal tubes are used.
What may be the harms of general anaesthesia? Intubation and extubation manoeuvres may prolong endoscopic room occupation time, post-anaesthesia care unit stay may be longer and about 30 to 70% of patients will suffer from sore throat (this is reduced if lidocaine is used).
Furthermore, orotracheal intubation may induce short time hemodynamic changes related to laryngoscopy.
What may be the benefits of deep sedation? The main advantage of sedation is probably the faster turnover in the intervention room. In the sole practice survey of anesthesiologists for endoscopy that is available, 81% of anaesthesiologists stated that they were using sedation, not general anesthesia, for ERCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patient with scheduled therapeutic ERCP
- •Written informed consent for the study protocol obtained from the patient or his/her legal representative
- •Anaesthetist available for the procedure
排除标准
- •Mechanically ventilated patients before the procedure
- •Baseline oxyhemoglobin saturation < 90%
- •Baseline systolic blood pressure < 90 mm Hg
- •American Society of Anaesthesiologists (ASA) physical score 5 (Table 1)
- •Age < 18 years
- •Pregnancy
- •Emergency procedure
- •Absence of fasting ≥ 6 hours for solids and ≥ 2 hours for clear liquids
- •Contraindication to any study drug
- •Short, thick neck or trismus that may complicate airway rescue
- •Previous documented difficult airway intubation
- •Obstructive sleep apnea
- •Severe swallowing disorders with documented broncho-aspiration
- •Bowel obstruction
- •Inclusion in the present protocol during the 30 preceding days
研究组 & 干预措施
Deep Sedation
Remifentanil 1ng/ml throughout the procedure. Propofol administration starts at an initial (estimated plasma) target concentration of 1,5 microg/ml.
Propofol administration is adjusted to level 1 or 2 on the modified observer's assessment of alertness/sedation scale. The propofol infusion will be increased stepwise by 0,5 microg/ml every 1 minute until loss of consciousness. Propofol is continued while maintaining spontaneous ventilation without assistance and systolic blood pressure ≥ 60 % of baseline systolic blood pressure.
干预措施: Propofol (Drug)
General Anaesthesia
General anesthesia will be induced with target controlled infusion (TCI) of propofol and remifentanil as in the group "deep sedation".
Suxamethonium (succinylcholine) will be used to facilitate intubation. Endotracheal tube balloon pressure will be controlled during the procedure. Ventilation will be assisted using 40% oxygen in air mixture and mechanically controlled using an anaesthetic ventilator.
干预措施: General anesthesia (Other)
结局指标
主要结局
ERCP success rate
时间窗: 24 hours
The primary study outcome will be a comparison between patient allocation groups and the percentage of completely successful ERCP. Success of ERCP is defined as achieving both high completion and low adverse event rate.
次要结局
- Success of ERCP in subgroups of patients(24 hours)
研究者
vincent huberty
MD
Erasme University Hospital