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Study aim
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This study was designed to compare the effect of two methods of anesthesia (total intravenous anesthesia with propofol and inhalational anesthesia with isoflurane) on postoperative nausea and vomiting in patients undergoing elective laparoscopy.
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Design
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Randomized, single-blinded, parallel, clinical trial, phase 3
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Settings and conduct
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Randomization on an individual level using 4 number blocks created in excel software. Allocation concealment has been carried out. Given the patient's anesthesia after receiving the induction which is identical in both groups, the patient is blind to the type of anesthesia, due to the apparent difference between the two types of anesthesia (inhaler jet mask and intravenous injections). Anesthesiologist (PI) and researcher are not blind to the type of anesthesia and the study is conducted in a single-blinded manner. Data collectors and data analysts have also been blinded. This is study was conducted in Imam Khomeini Hospital Complex. The incidence and severity of nausea and vomiting was evaluated and recorded at 0, 6, 12, and 24 hours after the surgery.
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Participants/Inclusion and exclusion criteria
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All patients aged 18-65, with ASA class I and II who underwent elective laparoscopy, were included. In the case of emergency surgery, the history of motion sickness or PONV, Positive drug Allergy history, use of anti-emetic drug or unwillingness of the patient, the case was excluded.
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Intervention groups
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. In the inhalation group, Isoflurane %1.5-1.7 in combination with 1cc Fentanyl and 1cc Atracurium were used every 45-60 minutes during the operation. In the intravenous group, 50cc of Propofol 1% was combined with 1-2cc of Remifentanil and was intravenously infused at the speed of 15-20cc/hr
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Main outcome variables
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Postoperative nausea and severity in 0, 2, 6, 12, 24 hours after surgery
Postoperative vomiting and severity at 0, 2, 6, 12, 24 hours after surgery