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IRCT20100920004780N11 IRCT 2021-01-16 Mashhad University of Medical Sciences Effect of local Dexmedetomidine on postoperative pain in perianal surgeries Investigation of the effect of local Dexmedetomidine on postoperative pain in perianal surgeries 2020-08-29 anticipated 50 Complete https://irct.ir/trial/53599 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: This double-blind clinical trial has a control group and an intervention group in which only the intervention group receives medication. Upon entering the study, an envelope is assigned to each patient, which puts them either in the control or intervention group. The patient and the researcher are unaware of the contents of each envelope. 2-3 Disease of anus. Intervention 1: Intervention group: At the end of the surgery, patients in this group are injected with 1.5 μg/kg diluted dexmedetomidine with a volume of 10 cc in the perianal area. Intervention 2: Control group: In this group, patients do not receive medication. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Dr. Mohammad Alipour
Ghaem hospital, Ahmad Abad blvd
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3840 0000 alipourm@mums.ac.ir Mashhad University of Medical Sciences scientific Mohammad Alipour
Ghaem hospital, Ahmad Abad blvd
Mashhad Iran (Islamic Republic of) 9176999311 +98 51 3840 0000 alipourm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Class I and II ASA candidate for perianal surgery (fissures and hemorrhoids) 18 years 60 years Both Advanced diabetes which leads to neuropathy Neuromuscular diseases Psychological and neurological diseases Drug addiction Use of analgesics or NSAIDs within the last 24 hours Pregnancy Body Mass Index is more than 23 Preoperative hearth rate is less than 45 Second or third-degree AV block Use of antihypertensive drugs including methyldopa, clonidine and other alpha 2 adrenergic agonists K62.9 Disease of anus and rectum, unspecified Treatment - Drugs N/A Intervention group: At the end of the surgery, patients in this group are injected with 1.5 μg/kg diluted dexmedetomidine with a volume of 10 cc in the perianal area. Control group: In this group, patients do not receive medication. Pain intensity. Timepoint: 1,3,6,12 and 24 hours after operation. Method of measurement: Using Visual Analogue Scale and verbal assessment on a scale of 1 to 10. Nausea. Timepoint: 1,3,6,12 and 24 hours after operation. Method of measurement: Clinical observations. Vomiting. Timepoint: 1,3,6,12 and 24 hours after operation. Method of measurement: Clinical observations. Vital signs including blood pressure and heart rate. Timepoint: Up to 24 hours after surgery. Method of measurement: Patient monitoring devices. Mashhad University of Medical Sciences Approved 2020-07-29 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhahd Razavi Khorasan Iran (Islamic Republic of)