Goal Directed Propofol Sedation With Magnesium Sulphate Versus Dexmedetomidine for ERCP Procedure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total propofol consumption
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive longer endoscopic procedure. It is performed in remote locations under a continuum of anesthetic depth, ranging from conscious to deep sedation leading to general anesthesia.
Propofol sedation for (ERCP) procedures is the most popular current technique that has generated controversy in the medical field. Propofol can be safely administered because of its shorter half-life which results in a shorter recovery time than conventional sedation (opioid and/or benzodiazepine) that makes it widely used for sedation in many gastrointestinal procedures including ERCP. However, because of its narrow therapeutic window, the level of conscious sedation can easily go deeper from moderately deep sedation to near general anesthesia. Therefore, propofol as a sole agent can cause oversedation and apnea. Depth of sedation could be estimated better when target effect concentration of propofol is titrated by using bispectral index monitoring device(BIS).Targeting BIS within a specific range ensures additional safety during the procedure. Scores between 60-80 have been recommended for sedation. Propofol requirement can be reduced with addition of adjuvants (eg. Ketamine, Magnesium sulfate and Dexmedetomidine). Most adjuncts have analgesic properties with opioid and anesthetic sparing effects, without clinically significant respiratory depression.
Dexmedetomidine, is a selective alpha 2 agonist; it has sedative, amnestic, and analgesic properties. It is a useful addition to a propofol/remifentanil anesthetic combination as it reduced their requirements intraoperatively and can help supplement analgesia postoperatively. Its combination with propofol was proved to provide satisfactory anesthesia for upper gastrointestinal (GI)) endoscopy in obstructive sleep apnea patients .
Magnesium can also act as an adjuvant in analgesia due to its properties as calcium channel blocker and N-methyl-D-aspartate antagonists .It was suggested to be a near ideal intravenous (IV) adjunct to propofol/ remifentanil based total anesthesia in gynaecology patients .
Hypothesis of this study is that Magnesium sulfate can have a propofol sparing effect during ERCP procedures guided by BIS monitoring as efficient as dexmedetomidine but with less cost and complications together with more patient and doctor satisfaction in addition to better patient outcome.
详细描述
After Theodor Bilharz Research Institute (TBRI) Ethics Committee approval, sixty patients scheduled for ERCP procedures will be informed about the study and written consents will be obtained.
Patients will be allocated into two groups, thirty patients each, Magnesium (M) and Dexmedetomidine (D). Group (M) will receive 40 mg.kg-1 of magnesium sulphate bolus followed by IV infusion of 10 mg.kg-1.h-1. Group (D) will receive dexmedetomidine bolus (1μg.kg-1) followed by infusion of 0.5μg.kg-1h-1 all through the procedure.
Randomization of the patients will be established by computer generated random number table utilizing sealed envelope technique.
On arrival to the ERCP suit, two IV cannulae will be inserted in both hands of each patient in both groups. One for isotonic saline infusion and propofol administration and the other will be preserved for the study drug administration. IV fluid will be started at a rate of 8-12 ml.kg-1.h-1 continued throughout the procedure. All patients will be premedicated with intravenous pantoprazole 40mg and ondansetron 8mg.
Routine monitoring of ECG, pulse oximetry, non-invasive blood pressure will be established before induction of sedation. BIS three electrodes sensor will be applied over the patient's forehead using fronto-temporal montage for the monitoring of level of sedation . The baseline variables will be recorded and documented as well as continuous monitoring and documentation every 5 min for the first 30 min and every 10 min till the end of procedure. Supplemental oxygen will be administered with nasal prongs at 3 l.min-1. The total duration of the procedure, defined as the time taken from insertion of the endoscope to its removal, will also be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) I, II or III.
- •Body mass index (BMI) ˂30
- •Patients scheduled for ERCP procedures
排除标准
- •Obesity (BMI >30)
- •Evidence of hepatic encephalopathy, ascites.
- •Sever renal, endocrine and respiratory dysfunction.
- •Atrioventricular conductance disturbance.
- •Symptomatic bradycardia <35 bpm
- •Hemodynamically unstable patients on inotropic support.
- •Neurological disorders
- •Myasthenia gravis.
- •Hypo/Hyperkalemia (Potassium <3meq/l or>5.5meq/l) (risk of dysrhythmias).
- •Chronic treatment with calcium channel blockers or magnesium
- •Opioid or analgesic abuse
- •Allergy to Propofol/ egg or any other study drugs.
- •Pregnancy and lactation
研究组 & 干预措施
Dexmedetomidine
1microgram/kilogram loading dose followed by 0.5 microgram/kilogram/hour IV
干预措施: Dexmedetomidine (Drug)
Magnesium sulphate
40milligram/kilogram loading dose followed by 10milligram/kilogram/hour IV
干预措施: Magnesium Sulphate (Drug)
结局指标
主要结局
Total propofol consumption
时间窗: through study completion, an average of one hour
0.5-1.5 mg as induction dose guided by bispectral index between 60-70 followed by infusion ranged from 3-5 mg/kg/h keeping BIS between 60-70
次要结局
- Cost(through study completion , an average of one hour)
- Heart rate(through study completion, an average of one hour)
- Mean arterial blood pressure(through study completion, an average of one hour)
- Complication and side effects(through study completion , an average of one hour)
- Time to discharge(15 minutes)
研究者
khalda G Moustafa
Professor of anesthesiology
Theodor Bilharz Research Institute