Patients aged between 20 and 70 years, ASA physical status I-III, and scheduled for laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study. Patients will be randomized to the preemptive group to receive an antiemetic regime 1h before the start of surgery or to the intraoperative group to receive the same antiemetic drugs in the same doses intraoperatively, 30 min before the end of surgery. In the operating room standard monitoring and a standardized anesthetic technique will be implemented in all patients. Nausea, vomiting, retching and PONV (cumulative) will be recorded at PACU, at 4h, 8h and 24h postoperatively. Pain scores assessed by NRS (numerical rating scale) will be recorded at the same time points. Also, when patients received fluids and solid food by mouth will be recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
115
Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively
Aretaieio University Hospital
Athens, Attica, Greece
PONV (postoperative nausea vomiting combined)
Incidence of combined nausea and vomiting postoperatively
Time frame: 24 hours
postoperative nausea frequency and intensity
numerical rating scale of nausea intensity (0-10)
Time frame: 24 hours
postoperative vomiting frequency
number of vomits
Time frame: 24 hours
postoperative pain
numerical rating scale of pain intensity (0-10)
Time frame: 24 hours
retching
if retching exists
Time frame: 24 hours
PONV (postoperative nausea vomiting combined)
frequency and intensity of nausea and vomiting
Time frame: 24 hours
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