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IRCT20200402046915N2 IRCT 2022-02-19 Shahid Beheshti University of Medical Sciences The effect of pregabalin on pain and anxiety in patients undergoing PCNL surgery The effect of preoperative administration of pregabalin on anxiety and pain in patients after PCNL 2022-04-03 anticipated 100 Complete https://irct.ir/trial/56666 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients randomly choose a number between 1 and 100 based on the priority of entering the medical center and hospitalization. Then they open the sealed envelope they want to match the selected number. The envelopes contain the letters A, B, C and D, according to which patients are randomly divided into 4 groups, Blinding description: Study participants are not aware of their assigned group and will be unaware of the drug used. Of course, they participate in the study with informed consent. 3 Calculus of kidney. Intervention 1: Intervention group: Patients receiving pregabalin. Intervention 2: Control group: Patients receiving placebo. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome can be shared. When: Start of access period 6 months after publishing the results. To whom: Our data will only be available to researchers working in the academic centers. Conditions: Possible analyzes are performed in SPSS software. Where to obtain: Applicants should email the following e-mail address to receive the documents: sah.hojjati@sbmu.ac.ir How to obtain: The applicant can submit his / her request and receive the documents 6 months after the publication of the results via the following e-mail: sah.hojjati@sbmu.ac.ir Comments:
public Seyyed Ali Hojjati
Shohada Tajrish Hospital, Shahrdari Street, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 sah.hojjati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyyed Ali Hojjati
Shohada Tajrish Hospital, Shahrdari Street, Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8001 sah.hojjati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years The patient undergoes PCNL surgery ASA class 1 or 2 18 years 60 years Both Use of drugs that interact with pregabalin, including: (rosiglitazone - pioglitazone - benzodiazepines - ACEIs) People who drink alcohol History of psychiatric disorders including suicidal ideation and depression History of Heart Failure History of Renal Failure Pregnant or lactating women N20.0 Calculus of kidney Prevention Placebo Intervention group: Patients receiving pregabalin Control group: Patients receiving placebo Postoperative pain. Timepoint: 2, 6, 12 and 24 hours after surgery. Method of measurement: VAS questionnaire. Anxiety before surgery. Timepoint: 2 hours before surgery and 0.5 hours before surgery. Method of measurement: Hamilton (HAM-A) questionnaire. Side effects of pregabalin. Timepoint: After the surgery. Method of measurement: A checklist of pregabalin side effects will be prepared and the patient will be asked after surgery. Shahid Beheshti University of Medical Sciences Approved 2022-01-09 Ethics committee of Shahid Beheshti University of Medical Sciences Shohada Tajrish Hospital, Shahrdari Street, Tajrish Square Tehran Tehran Iran (Islamic Republic of)