Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography ERCP: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 主要终点
- Incidence of PONV
研究概览
简要总结
This study is designed to compare the effects of a single dose Ondansetron 4mg versus Palonosetron 75mcg in the prophylaxis against early & delayed postoperative nausea and vomiting in the first 48 hours post-operatively in patients undergoing Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to determine the complete response, complete control and failure rates.
详细描述
Premedication will be omitted. Pre-operative baseline values of heart rate and blood pressure will be recorded. On arrival in the operation theatre, the routine monitoring devices (ECG, Pulse Oximetry & Non Invasive Blood Pressure) will be applied and base line heart rate, blood pressure (Systolic, diastolic and mean arterial blood pressure) and arterial Oxygen saturation will be recorded.
After an intravenous line is secured, while pre-oxygenating the patient. Anaesthesia will be induced using fentanyl 1-2 µg/kg and sodium propofol 1.5-2.5 mg/kg according to the patient general condition and hemodynamics and intubation will be facilitated by using atracurium besylate 0.5mg/kg.
Anaesthesia will be maintained with O2 in air (50%), sevoflurane (0.8-1.0 MAC). Muscle relaxation will be maintained with boluses of atracurium besylate 0.1 mg/kg. Intermittent positive pressure ventilation will be adjusted to maintain end tidal carbon dioxide between 30-35mm Hg. Intravenous crystalloids (3-4 ml/kg/hr) will infused during intra-operative and immediate post-operative period. Intra-operatively, the following parameters will be monitored: ECG, blood pressure, pulse rate, end tidal carbon dioxide (ET CO2) & oxygen saturation (SpO2). Diclofenac sodium 1mg/kg intramuscularly to protect against Post ERCP Pancreatitis & Paracetamol (1gm) intravenously will be administered 15 minutes before the end of procedure followed by the administration of the anti-emetic prophylaxis according to group allocation.
At the end, residual neuromuscular block will be antagonized using atropine and neostigmine and trachea will be extubated after signs of adequate neuro-muscular reversal are achieved. After extubation, patients will be transferred to the Post anaesthesia care unit where the blood pressure, heart rate, respiratory rate and O2 saturation will be monitored continuously every five minutes for 60 minutes.
If Visual Analogue Score (VAS) score is ≥3, rescue analgesia will be provided with Pethidine in 10mg increments / 5minutes until the VAS score is less than 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-60 years of age
- •American Society of Anaesthesiologists physical status (ASA) grade I-II
- •1 - 2 Risk factor for PONV according to Apfel Score
- •o Apfel Score includes 4 points : Female gender, history of PONV and/or motion sickness, non-smoking status, and post-operative use of opioids , the risk of PONV is 10%, 20%, 40%,60% or 80% respectively
- •Undergoing elective ERCP.
- •Having provided written informed consent signed by patient or guardian.
排除标准
- •Allergy to any drug being used in the study
- •ASA III-IV
- •History of vomiting, retching, nausea or antiemetics use in the 24 hours prior to day of procedure
- •Patients receiving steroids, prokinetics, or antacids intake in the previous 48 hours
- •Patients with significant gastro-oesophageal disease
- •Menstruating, lactating or pregnant females
- •History of alcohol or substance abuse
- •Significant systemic disease of the liver, kidneys, heart, lungs, Cancer and or diabetes mellitus.
研究组 & 干预措施
Group O
On the day of procedure, the recruited patients in Group O will be given Ondansetron 4 mg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care & will label the syringes as antiemetic.
干预措施: Ondansetron 4 mg (Drug)
Group P
On the day of procedure, the recruited patients in Group P will be given Palonosetron 75 mcg diluted for up to 5ml using normal saline by a colleague not participating to the study or the patient care & will label the syringes as antiemetic.
干预措施: Palonosetron 75 mcg (Drug)
结局指标
主要结局
Incidence of PONV
时间窗: During 24 hours post-operatively
Incidence of nausea, retching or vomiting
次要结局
- Incidence of PONV(During 48 hours post-operatively)
- Complete Responders(During 48 hours postoperatively)
- Complete control(During 48 hours postoperatively)
- Failed prophylaxis(During 48 hours postoperatively)
- Time to rescue anti-emetics or emesis(Time in minutes during 48 hours postoperatively)
研究者
Hanan Farouk Khafagy
Professor doctor
Theodor Bilharz Research Institute