]>
IRCT20181104041550N1 IRCT 2022-01-13 Iran University of Medical Sciences The effect of dexmedetomidine injection on analgesia in patients after chest surgery The effect of dexmedetomidine injection in epidural block on analgesia in patients after thoracotomy. 2021-12-22 anticipated 40 Complete https://irct.ir/trial/60501 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, we divide 4 people into groups, 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 Chest surgery. Intervention 1: Intervention group: First, one liter of normal saline (made by Samen Pharmaceutical Company) is injected intravenously for the patient, then the patient is placed in a sitting position, and under sterile conditions, thoracic vertebrae seven to ten are identified. An 18 gauge needle is inserted using the paramedian method and 3 cc of lidocaine (made by Samen Pharmaceutical Company) will be injected through the needle. Then an epidural catheter is inserted through the needle.Then 6 mg of ropivacaine 0.1% (made by Royan Daru Pharmaceutical Company) and 1 mg of dexmedetomidine (made by Mehrdaro Pharmaceutical Company)as a bolus are injected through an epidural catheter before surgical incision and then as an epidural infusion (4 mg of ropivacaine 0.1% and 1 mg dexmedetomidine) will be continued during surgery and up to 48 hours after surgery. Intervention 2: Control group: First, one liter of normal saline (made by Samen Pharmaceutical Company) is injected intravenously for the patient, then the patient is placed in a sitting position, and under sterile conditions, thoracic vertebrae seven to ten are identified. An 18 gauge needle is inserted using the paramedian method and 3 cc of lidocaine (made by Samen Pharmaceutical Company) will be injected through the needle. Then an epidural catheter is inserted through the needle.Then 6 ml of rupivacaine 0.1%(made by Royan Daru Pharmaceutical Company) is injected through an epidural catheter before surgical incision and continues with an infusion of 4 mg of rupivacaine 0.1% during surgery and up to 48 hours after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public SaeidReza Entezary
Sattar Khan St., Niayesh St., Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) 8874113911 +98 21 6651 5758 entezary.sr@iums.ac.ir Iran University of Medical Sciences scientific SaeidReza Entezary
Sattar Khan St., Niayesh St., Rasoul Akram Hospital
Tehran Iran (Islamic Republic of) 8874113911 +98 21 6651 5758 entezary.sr@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Candidate patients for thoracotomy surgery ASA physical class < or = class III 18 years 70 years Both Treatment with alpha adrenergic antagonists Contraindications to epidural catheter placement Patients who do not have the possibility of extubation after surgery G89.22 Chronic post-thoracotomy pain Treatment - Drugs Treatment - Drugs Intervention group: First, one liter of normal saline (made by Samen Pharmaceutical Company) is injected intravenously for the patient, then the patient is placed in a sitting position, and under sterile conditions, thoracic vertebrae seven to ten are identified. An 18 gauge needle is inserted using the paramedian method and 3 cc of lidocaine (made by Samen Pharmaceutical Company) will be injected through the needle. Then an epidural catheter is inserted through the needle.Then 6 mg of ropivacaine 0.1% (made by Royan Daru Pharmaceutical Company) and 1 mg of dexmedetomidine (made by Mehrdaro Pharmaceutical Company)as a bolus are injected through an epidural catheter before surgical incision and then as an epidural infusion (4 mg of ropivacaine 0.1% and 1 mg dexmedetomidine) will be continued during surgery and up to 48 hours after surgery. Control group: First, one liter of normal saline (made by Samen Pharmaceutical Company) is injected intravenously for the patient, then the patient is placed in a sitting position, and under sterile conditions, thoracic vertebrae seven to ten are identified. An 18 gauge needle is inserted using the paramedian method and 3 cc of lidocaine (made by Samen Pharmaceutical Company) will be injected through the needle. Then an epidural catheter is inserted through the needle.Then 6 ml of rupivacaine 0.1%(made by Royan Daru Pharmaceutical Company) is injected through an epidural catheter before surgical incision and continues with an infusion of 4 mg of rupivacaine 0.1% during surgery and up to 48 hours after surgery. Patients pain rate. Timepoint: Up to 48 hours after surgery. Method of measurement: Visual Analogue Scale. Adequate respiratory ventilation. Timepoint: Up to 48 hours after surgery. Method of measurement: Observation. Iran University of Medical Sciences Approved 2021-01-18 Ethics committee of Iran University of Medical Sciences Hemmat Highway next to Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)