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IRCT20141209020258N185 IRCT 2023-05-30 Arak University of Medical Sciences Comparison of the effect of arterial carbon dioxide pressure and nausea, vomiting and pain after laparoscopic cholecystectomy Comparison of the effect of arterial carbon dioxide pressure and nausea, vomiting and pain after laparoscopic cholecystectomy 2023-06-06 anticipated 60 Complete https://irct.ir/trial/70222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: Due to the double-blindness of the study, the patients and the data collector (intern) do not know about the groupings, but the anesthesiologist who is on the patient's bed during surgery knows about the groupings. N/A Laparoscopic cholecystectomy. Intervention 1: The first intervention group: in one group, patients will receive standard CO2 gas pressure (14-15 mmHg) during surgery. Intervention 2: The second intervention group: In the second group, they will receive low pressure CO2 gas (7-9 mm Hg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public 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 scientific Dr Behnam Mahmodie
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mahmodie@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Age: 18 to 65 years old ASA class I and II Candidate for laparoscopic cholecystectomy surgery No chronic use of narcotics, NSAIDs and benzodiazepines 18 years 65 years Both Changing laparoscopic surgery to open surgery Extending the operation time more than 3 hours The need for blood transfusion during the operation Dissatisfaction to continue attending the study K91.86 Retained cholelithiasis following cholecystectomy Treatment - Surgery Treatment - Surgery The first intervention group: in one group, patients will receive standard CO2 gas pressure (14-15 mmHg) during surgery. The second intervention group: In the second group, they will receive low pressure CO2 gas (7-9 mm Hg). Arterial blood gas. Timepoint: The beginning of the action and the end of the action. Method of measurement: Blood test. Nausa. Timepoint: From the time of entering recovery and every 15 minutes to one hour and 2, 4, 8, 12 and 24 hours after surgery. Method of measurement: Physical examination. Vomitting. Timepoint: From the time of entering recovery and every 15 minutes to one hour and 2, 4, 8, 12 and 24 hours after surgery. Method of measurement: Physical examination. Pain. Timepoint: Recovery and 4 hours after surgery. Method of measurement: Visual analog scale of pain. Mean Ondansetron. Timepoint: At the end of the study. Method of measurement: Physical examination. Arak University of Medical Sciences Approved 2023-04-16 Ethics Committe Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)