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IRCT20141209020258N119 IRCT 2019-08-16 Arak University of Medical Sciences Comparison of two kine of tourniquet in terms of the onset and duration of analgesia and pain of the tourniquet and the return of sensation and movement In the distal upper extremity surgery Comparison of double tourniquet of arm and forearm in terms of the onset and duration of analgesia and pain of the tourniquet and the return of sensation and movement In the distal upper extremity surgery 2019-04-09 anticipated 70 Complete https://irct.ir/trial/39794 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B. In this method, we selected a number of cards or letters as an intervention and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size.‏, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind). Outcome assessor and analyzer and participant don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor. 2-3 Distal upper extremity fracture. Intervention 1: Intervention group: We will inject 40 milliliter of Lidocaine 0.5% (Daropakhsh Co) plus 1microgram in kilogram Dexmedetomidin (ٍExir Co) in the double-arm tourniquet arm.A double-cuff tourniquet will be placed on the proximal arm, and the patient’s blood pressure will be measured before the inflation of the tourniquet. After exsanguination with an esmarch bandage, the cuff will be inflated to a pressure 150 mmHg above the systolic blood pressure. Intervention 2: Intervention group: We will inject 20 milliliter of Lidocaine 0.5% (Daropakhsh Co) plus 0.5 microgram in kilogram Dexmedetomidin (Exir Co) in double tourniquet forearm.It inject through the dorsal vein of the organ that Surgery is performed on it.A double-cuff tourniquet wiil be placed on the proximal arm, and the patient’s blood pressure will be measured before the inflation of the tourniquet. After exsanguination with an esmarch bandage, the cuff will be inflated to a pressure 150 mmHg above the systolic blood pressure. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: researcher in university Conditions: If there are additional questions Where to obtain: Dr Modir How to obtain: They have to write letters to the professors and the university Comments:
public Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific 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 Iran (Islamic Republic of) Both gender Age 50 to 20 years ASA class 1 and 2 Duration of surgery is within 40 to 90 minutes No pregnancy Absence of Raynaud's disease and scleroderma Lack of peripheral vascular disease Absence of methemoglobinemia and sickle cell disease Lack of underlying illness No addiction Lack of epilepsy Lack of Kidney failure Distal upper extremity fracture 20 years 50 years Both Patient dissatisfaction Hemoglobin is less than 10 Consumers of calcium channel blockers or beta-blockers S52 Fracture of forearm Treatment - Other Treatment - Other Intervention group: We will inject 40 milliliter of Lidocaine 0.5% (Daropakhsh Co) plus 1microgram in kilogram Dexmedetomidin (ٍExir Co) in the double-arm tourniquet arm.A double-cuff tourniquet will be placed on the proximal arm, and the patient’s blood pressure will be measured before the inflation of the tourniquet. After exsanguination with an esmarch bandage, the cuff will be inflated to a pressure 150 mmHg above the systolic blood pressure. Intervention group: We will inject 20 milliliter of Lidocaine 0.5% (Daropakhsh Co) plus 0.5 microgram in kilogram Dexmedetomidin (Exir Co) in double tourniquet forearm.It inject through the dorsal vein of the organ that Surgery is performed on it.A double-cuff tourniquet wiil be placed on the proximal arm, and the patient’s blood pressure will be measured before the inflation of the tourniquet. After exsanguination with an esmarch bandage, the cuff will be inflated to a pressure 150 mmHg above the systolic blood pressure. Mean arterial blood pressure. Timepoint: Before intervention, 5, 10, 15, 20 minutes and then every 10 minutes to end of surgery and after emptying the tourniquet and recovery. Method of measurement: Barometer. Heart rate. Timepoint: Before intervention, 5, 10, 15, 20 minutes and then every 10 minutes to end of surgery and after emptying the tourniquet and recovery. Method of measurement: Count. Percent of oxygen saturation. Timepoint: Before intervention, 5, 10, 15, 20 minutes and then every 10 minutes to end of surgery and after emptying the tourniquet and recovery. Method of measurement: Pulse oximetry. Duration of motor block. Timepoint: Every 5 minute. Method of measurement: Minute. Duration of sensory block. Timepoint: Every 1minute. Method of measurement: Minute. Mean use of narcotic. Timepoint: 24 hour after surgery. Method of measurement: Milligram. Pain. Timepoint: After filling the tourniquet, at the time of 15, 30 and 45 and every 15 minutes until the end of surgery. Method of measurement: Visual Analogue Scale Questionnaire. Arak University of Medical Sciences Approved 2019-04-07 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)