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IRCT20210830052338N1 IRCT 2021-10-23 Zanjan University of Medical Sciences ُStudy of the effect of decrease in carbon dioxide pressure on pain in patients with gallbladder inflammation after laparoscopy Study of the effect of decrease in carbon dioxide pressure on pain in patients with cholecystitis after laparoscopic cholecystectomy 2021-09-23 anticipated 72 Complete https://irct.ir/trial/58624 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: In this study at least 30 samples were calculated in each intervention and control group ( Based on the sample size formula with a type one error 5% and 80% power) which is required according to the type of randomization to 36 samples in each group. Patient randomization is done on Block Randomization basis with permutations ABAB, ABBA, AABB, BBAA, BABA, BABA. Each block is randomly selected and patients will be assigned to two groups A and B based on the permutation sequence. In Block Randomization the number of participants, 3 patients in each block, in the consecutive time intervals are entered into intervention and control groups. This study has parallel design namely any group of participants exposed to one of the study interventions. For random assignment of Random allocation software is used. These random sequencing production software in addition to simple randomization are able to generate random sequencing by blocking method, Blinding description: This study is double blind for participant, clinical care, researcher, impact assessor and data analyzer so that these people are not informed of carbon dioxide gas pressure and the only surgeon is notified of gas pressure. 3 Cholecystitis. Intervention 1: Intervention group: Patients are candidate for laparoscopic cholecystectomy surgery with low carbon dioxide gas pressure(8-10mmHg). Intervention 2: Control group: Patients are candidate for laparoscopic cholecystectomy surgery with standard carbon dioxide gas pressure(12-14mmHg). Yes - There is a plan to make this available What will be shared: All data can be shared after identifying individuals. When: Access period starts from 2022 To whom: The data will be available to all researchers working in academic and scientific institutions, as well as to those working in industry. Conditions: The data will be available to start a similar clinical trail. Where to obtain: Individuals cab refer to dr.yalda.yusefi@gmail.com to receive data. How to obtain: The data will be provided to the applicant at the earliest opportunity. Comments:
public Dr. Naser Keikhali
Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956111 +98 24 3314 0201 nkeikhali@zums.ac.ir Zanjan University of Medical Sciences scientific Dr. Naser Keikhali
Ayatollah Mousavi Hospital
Zanjan Iran (Islamic Republic of) 4513956111 +98 24 3314 0201 nkeikhali@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Cholecystitis Patient satisfaction 20 years 75 years Both Liver disease Heart disease CNS disease Kidney disease Pregnant women Addiction History of abdominal surgery Patient dissatisfaction Use of analgesics K81 Cholecystitis Treatment - Surgery Treatment - Surgery Intervention group: Patients are candidate for laparoscopic cholecystectomy surgery with low carbon dioxide gas pressure(8-10mmHg) Control group: Patients are candidate for laparoscopic cholecystectomy surgery with standard carbon dioxide gas pressure(12-14mmHg) Severity of pain. Timepoint: 6 ,12 ,24 hours after the operation. Method of measurement: Visual Analog Scale. Zanjan University of Medical Sciences Approved 2021-08-25 Ethics committee of Zanjan University of medical Sciences Zanjan University of Medical Sciences , Shahid Avini dormitory Zanjan Zanjan Iran (Islamic Republic of)