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IRCT20141209020258N117 IRCT 2019-07-13 Arak University of Medical Sciences Comparison Intraperitoneal Ropivacaine alone and with Dexmedetomidin and Fentanyl on pain management in abdominal laparoscopic Comparison Intraperitoneal Ropivacaine alone and with Dexmedetomidin and Fentanyl on pain management in abdominal laparoscopic 2019-01-05 anticipated 138 Complete https://irct.ir/trial/39026 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in three groups A and B and C.‏ In this method, we wrote on some cards intervention group1 and the same ‎number of cards for intervention group 2 and the same ‎number of cards for the control group, then the cards were mixed in a container. One card was taken out and its ‎allocation was registered and the card was returned to the container. Then the cards were mixed again and another card was taken. This process continued to reach a random sequence ‎according to sample size.‏, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. ِDefinition of groups A and B and C are available to analyzer and outcome assessor. 2-3 abdominal elective laparoscopic. Intervention 1: Control group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) use that total volume of it is adjusted to 50 milliliter with normal saline (Daropakhsh.Co). Intervention 2: Intervention group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram per kilogram Dexmedetomidine (Exir Co.Iran). Intervention 3: Intervention group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram in kilogram Fentanyl (Aboreyhan Co.Iran). Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Modir How to obtain: They have to write letters to the professors and the university Comments:
public Dr Bijan Yazdi
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 yazdi@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients candidate laparoscopic abdominal surgery 18 to 65 years old No susceptibility to used drugs Absence of cardiovascular disease and endocrine and renal disease No smoking and no addiction No pregnancy Body mass index more than 35 18 years 65 years Both No willingness to continue the study Refusal of the patient to inject intraperitoneally Patient that requires the insertion of a drain inside the abdomen for any reason Treatment - Drugs Treatment - Drugs Treatment - Drugs Control group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) use that total volume of it is adjusted to 50 milliliter with normal saline (Daropakhsh.Co). Intervention group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram per kilogram Dexmedetomidine (Exir Co.Iran). Intervention group: 2 milligram per kilogram Ropivacaine 0.5 % (Molteni Co.Italia) plus 1 micro gram in kilogram Fentanyl (Aboreyhan Co.Iran). Mean arterial blood pressure. Timepoint: Every 30 minutes during surgery and recovery and 2 hours after surgery. Method of measurement: Barometer. Heart rate. Timepoint: Every 30 minutes during surgery and recovery and 2 hours after surgery. Method of measurement: Count. Percent of oxygen saturation. Timepoint: Every 30 minutes during surgery and recovery and 2 hours after surgery. Method of measurement: Pulse oximetry. Pain. Timepoint: At recovery and 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Visual Analogue Scale Questionnaire. Amount of opioids consumed during surgery. Timepoint: End of surgery. Method of measurement: Milligram. Arak University of Medical Sciences Approved 2018-12-30 Ethics committee Arak University Of Medical Sciences Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)