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IRCT20210607051501N1 IRCT 2021-10-24 Iran University of Medical Sciences The effect of hypertension due to cholecystectomy surgery on postoperative pain The effect of pneumoperitoneum-induced hypertension during laparoscopic cholecystectomy under general anesthesia on postoperative pain compared with normal blood pressure induced by intravenous nitroglycerin 2021-07-23 anticipated 85 Complete https://irct.ir/trial/57450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups. To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block 4, we divide patients into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC, Blinding description: In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B. 3 Cholecystitis. Intervention 1: Intervention group: The intervention group includes patients who meet the inclusion criteria and undergo laparoscopic cholecystectomy. The intervention is surgery-induced pneumoperitoneum, which increases intraoperative blood pressure and postoperative pain. To clarify the hypothesis, the patient's blood pressure is measured at different times during the operation and its effect on postoperative pain is recorded at different times. The induced gas pressure is in the range of 14 to 16 cm of water. Intervention 2: Control group: In the control group, patients who meet the inclusion criteria and undergo laparoscopic cholecystectomy are included .In these patients, by injecting nitroglycerin (Manufactured by Caspiantamin Pharmaceutical Company) at a dose of 5 to 10 micrograms per minute with micro Burette Infusion Set until the patient reaches normal blood pressure and records it at different times during the operation, the amount of postoperative pain is recorded at different times. Yes - There is a plan to make this available What will be shared: All datas could be shared after unidentification of the participants. When: 6 months after publication To whom: The results and datas would be available for everybody Conditions: No limitation Where to obtain: The main author Dr Ali Khatibi, email address khatibi.al@iums.ac.ir How to obtain: Sending the request, assessment the request by the author of this study Comments:
public Ali Khatibi
Firoozgar hospital, Behafarin st., Karimkhan-e-zand st., Vali-asr sq.
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1600 khatibi.al@iums.ac.ir Iran University of Medical Sciences scientific Ali Khatibi
Firoozgar hospital, Behafarin st., Karimkhan-e-zand st., Vli-asr sq.
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1600 khatibi.al@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) No underlying disorders (ASA 1) Aged between 20 to 60 yr 20 years 60 years Both Having analgesic agent during last week Treatment - Other Rehabilitation Intervention group: The intervention group includes patients who meet the inclusion criteria and undergo laparoscopic cholecystectomy. The intervention is surgery-induced pneumoperitoneum, which increases intraoperative blood pressure and postoperative pain. To clarify the hypothesis, the patient's blood pressure is measured at different times during the operation and its effect on postoperative pain is recorded at different times. The induced gas pressure is in the range of 14 to 16 cm of water. Control group: In the control group, patients who meet the inclusion criteria and undergo laparoscopic cholecystectomy are included .In these patients, by injecting nitroglycerin (Manufactured by Caspiantamin Pharmaceutical Company) at a dose of 5 to 10 micrograms per minute with micro Burette Infusion Set until the patient reaches normal blood pressure and records it at different times during the operation, the amount of postoperative pain is recorded at different times. Postoperative pain score. Timepoint: The postoperative pain intensity (VAS) will record in hours 2, 8, 12 and 24 after surgery. Method of measurement: Visual Analogue Scale. Pethedine dosage after surgery. Timepoint: The total dose of pethedine used for pain control will record in hours 2, 8, 12 and 24 after surgery. Method of measurement: Data record forms. Iran University of Medical Sciences Approved 2020-05-10 Ethics committee of Iran University of Medical Sciences Firoozgar hospital, Behafarin st., Karimkhan-e-zand st., Vali_Asr sq Tehran Tehran Iran (Islamic Republic of)