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Study aim
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Comparison of the effect of intraperitoneal dexmedetomidine or intravenous dexmedetomidine in combination with intraperitoneal bupivacaine on pain after laparoscopic cholecystectomy.
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Design
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Randomised,with a control group, parallel group trial with blinded outcome assesment, randomisation was done with random allocation software.
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Settings and conduct
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This study is a triple-blineded randomized clinical trial on 90 patients who are candidates for laparoscopic cholecystectomy in Al-zahra operating room at isfahan city. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients will be randomly assigned into 3 groups,in each group the intended intervention is applied and the patient's data and symptoms are recorded. In case of any change in anesthesia method and change of operation to open type, patients will be excluded from the study. The patients, the researcher who records the patient's symptoms, and the analysts who analyze the collected data don't know the type of intervention applied in each group and therefore they are all blind.
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Participants/Inclusion and exclusion criteria
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•Inclusion criteria: candidate patiants for laparoscopic cholecystectomy surgery, age between 18-65 years old, ASA I & II.
•Excluision criteria: patients with a history of allergy to the drugs used in the study, patients with inability to express the intensity of pain based on the VAS criteria.
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Intervention groups
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Group 1: 20 ml bupivacaine 0.25% with dexmedetomidine at a dose of 1 μg/kg intraperitoneally, group 2: 20 ml bupivacaine 0.25% intraperitoneally and dexmedetomidine at a dose of 1 μg/kg iv.control group 22cc N/S intraperitoneal
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Main outcome variables
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vas pain score, dosage of additional analgesic, frequency of nausea & vomiting, palse rate, 02 saturation