Postoperative Nausea and Vomiting Clinical Trial
Official title:
Palonosetron Versus Ondansetron for PONV Prevention in Patients Undergoing Endoscopic Retrograde Cholangio-Pancreatography ERCP: A Prospective Randomized Controlled Study
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.
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.
Pain intensity will be assessed using VAS for the first 24 hours. Post-operative pain relief
will be provided Paracetamol (1gm) intravenously given regularly every 8 hours for the first
24 hours.
Any incidence of nausea, retching or vomiting and use of any rescue medication during the
first 24 hours at time interval of 0, 1/2, 1, 2, 6,12, 24 and 48 h will be noted, Nausea is
defined as the subjective sensation of an urge to vomit, in the absence of expulsive muscular
movements. Retching is defined as an unproductive effort to vomit. Vomiting is defined as the
forcible expulsion of the gastric contents through the mouth. Retching and vomiting will be
collectively termed emetic episodes.
Rescue anti-emetic therapy in the form of Metoclopramide 10 mg intravenously will be provided
for any patient suffering from an emetic episode as described above. The use of antiemetic
rescue medication will be recorded & analysed.
Patients will stay at the hospital post ERCP according to the discretion of the treating
physician opinion, if any patient will be discharged before 48 hours, the data will be
collected by telephone.
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