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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 vs inhalational anesthesia) on postoperative nausea and vomiting after elective abdominal laparotomic surgery
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Design
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phase 3, Parallel-group, single-blind, randomized clinical trial.
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Settings and conduct
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randomization on an individual level using 4 number blocks created in excel. allocation concealment was carried out. Given the patients' anesthesia after receiving the induction, the patient is blind to the kind of anesthesia. Due to the apparent difference between the two types of anesthesia (the mask vs IV medication) the anesthesiologist was not blind to the type of anesthesia, so the study was conducted in a single-blinded manner. The personals in charge of gathering and analyzing the data were blinded using codes for groups, to the identity of the patients. The study was conducted in Imam Khomeini Hospital Complex, Tehran. The incidence and severity of patients' nausea and vomiting were 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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Patients aged 18-65, with ASA class I and II who underwent elective abdominal laparotomic surgery were included. In the case of the history of PONV, Positive drug Allergy history or unwillingness of the patient, the patients were excluded.
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Intervention groups
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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/hour. Depending on the patients’ need the dosage was altered by ±5cc. In the inhalation group, Isoflurane % 1.5 -% 1.7 in combination with 1cc Fentanyl and 1cc Atracurium was used every 45-60 minutes.
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Main outcome variables
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Occurrence and severity of post-operative nausea in 0, 6, 12, 24 hours post-surgery
Occurrence and severity of vomiting in 0, 6, 12, 24 hours post-surgery