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IRCT20151107024909N11 IRCT 2021-10-09 Iran University of Medical Sciences Cis atracurium and Tourniquet Comparison of onset, duration and recovery time of neuromuscular blockage of Cis atracurium administration before and after inflation of Tourniquet on upper limb: Randomized clinical trial. 2021-09-23 anticipated 24 Complete https://irct.ir/trial/57526 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the Balanced Block Randomization method (block size=4). Random allocation software will be used for determining the sequences of blocks. In each block, there are two A for "After" and two B for "Before". For each eligible patient, the group are determined by randomized selected sequence, and after completing one block (n=4), the next randomized selected sequence will be used to complete next block until all of the eight blocks complete, Blinding description: No information will be provided to clinical caregivers, about which group receive the drug before or after inflation of tourniquet. N/A Cis atracurium. Intervention 1: Intervention group: The night before the operation, if there are conditions for inclusion in the study based on inclusion and exclusion criteria, regarding the study and actions taken in this study on the patient and its side effects and benefits are explained to the patient according to the consent form and satisfaction Is obtained. Based on the Balanced Block Randomization method, the patient is placed in one of groups A or B. In group A, up on entering the operating room, patients are non-invasively monitored for heart rate, blood pressure, and arterial blood oxygen saturation. Patients are also hydrated by a suitable peripheral vein and pre-oxygenated by a face mask. The tourniquet cuff (RS 3000 made by Ryan, CO. Iran) is closed around the arm which does not have a peripheral vein catheter and also the electrodes which detect train of four (TOF) contraction (TOF Watch SX Organon Ltd Swords, Co. Dublin Ireland) is placed in the wrist of both upper limbs over ulnar nerve and thumb to detect the contractions of adductor pollicis muscle. For sedation, patients received midazolam 0.05 milligram per kilogram of ideal body weight (mg/kg IBW) made by (EXIR, CO. Iran) and fentanyl one microgram per kilogram of ideal body weight (µg /kg IBW) made by (Caspian, CO. Iran) intravenously and after sedation of the patient, train of four (TOF) detector is calibrated. Induction of patients is started by administration of lidocaine 1/5 mg/kg IBW (made by Caspian, CO. Iran) and propofol 2 mg/kg IBW (made by Ferzenius Cabi, CO. Austria) and then Cis atracurium is administered intravenously at a dose of 0/02 mg/kg IBW, (made by Rosa Mod, CO. Iran) and the stopwatch is started immediately. When the TOF count, shows zero number of muscle contractions in one limb, this time indicates that complete block is obtained. At this time, tourniquet inflates through five seconds up to a pressure of 100 mm Hg over patient´s basic blood pressure, and the patient is intubated and the time to reach the block and the duration of the block and the recovery time in both limbs are measured separately. When the sequence of TOF remains zero, this period of time shows complete block. The time between the appearance of the first and second contraction (TOF=1 till 2) is considered as the recovery time. After recording the above parameters, the tourniquet is deflated and the anesthesia is continued with the administration of the appropriate muscle relaxant dose. Intervention 2: Control group: In group B, up on entering the operating room, patients are non-invasively monitored for heart rate, blood pressure, and arterial blood oxygen saturation. Patients are also hydrated by a suitable peripheral vein and pre-oxygenated by a face mask. The tourniquet cuff (RS 3000 made by Ryan, CO. Iran) is closed around the arm which does not have a peripheral vein catheter and also the electrodes which detect train of four (TOF) contraction (TOF Watch SX Organon Ltd Swords, Co. Dublin Ireland) is placed in the wrist of both upper limbs over ulnar nerve and thumb to detect the contractions of adductor pollicis muscle. For sedation, patients received midazolam 0.05 milligram per kilogram of ideal body weight (mg/kg IBW) made by (EXIR, CO. Iran) and fentanyl one microgram per kilogram of ideal body weight (µg /kg IBW) made by (Caspian, CO. Iran) intravenously and after sedation of the patient, train of four (TOF) detector is calibrated. Induction of patients is started by administration of lidocaine 1/5 mg/kg IBW (made by Caspian, CO. Iran) and propofol 2 mg/kg IBW (made by Ferzenius Cabi, CO. Austria) and then tourniquet inflates through five seconds up to a pressure of 100 mm Hg over patient´s basic blood pressure and then Cis atracurium is administered intravenously at a dose of 0/02 mg/kg IBW, (made by Rosa Mod, CO. Iran) and the stopwatch is started immediately. When the TOF count, shows zero number of muscle contractions in one limb, this time indicates that complete block is obtained. At this time, the patient is intubated and the time to reach the block and the duration of the block and the recovery time in both limbs are measured separately. When the sequence of TOF remains zero, this period of time shows complete block. The time between the appearance of the first and second contraction (TOF=1 till 2) is considered as the recovery time. After recording the above parameters, the tourniquet is deflated and the anesthesia is continued with the administration of the appropriate muscle relaxant dose. 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 The decision about publication of trial will be done after end of trial and related to its results.
public Saeed aghakhani
Anesthesiology Department, Firozgar Hospital, Behafarin St. Karimkhan Av.
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8894 6267 aghakhani.said@gmail.com Iran University of Medical Sciences scientific Faranak Rokhtabnak
Anesthesiology Department, Firozgar Hospital, Behafarin St. Karimkhan Av.
Tehran Iran (Islamic Republic of) 1593748711 +98 21 8894 6267 rolhtabnak.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Operation is elective Operation needs general anesthesia Body mass index is between 18 -30 Age is between 20 - 60 years 20 years 65 years Both History of liver disease History of kidney disease History of severe cardiopulmonary disease History of known neuromuscular disease such as: Guillain- Barre syndrome, Myasthenia gravis, Organophosphate and Anticholinesterase intoxication, multiple sclerosis disease and history of any musculoskeletal weakness in limbs Usage of drugs such as: Aminoglycosides, Polymyxin, Lincomycin, Clindamycin, Tetracycline, Calcium, Magnesium, Lithium, Verapamil, Amlodipine, Anti epileptic drugs, Furosemide, Dantrolene, Azathioprine, Steroid and Tamoxifen History of any vascular disease such as: Venous and arterial emboli, any impairment in circulation of limbs, Hemodialysis and history of any surgery on vessels of limbs. Sickle cell anemia Acidosis Infection in limbs Fracture in limbs Tumor in limbs Any increase in intracranial pressure Addicted patient Surgery on limbs that were examined If neuromuscular monitoring is necessary during operation Treatment - Devices Treatment - Devices Intervention group: The night before the operation, if there are conditions for inclusion in the study based on inclusion and exclusion criteria, regarding the study and actions taken in this study on the patient and its side effects and benefits are explained to the patient according to the consent form and satisfaction Is obtained. Based on the Balanced Block Randomization method, the patient is placed in one of groups A or B. In group A, up on entering the operating room, patients are non-invasively monitored for heart rate, blood pressure, and arterial blood oxygen saturation. Patients are also hydrated by a suitable peripheral vein and pre-oxygenated by a face mask. The tourniquet cuff (RS 3000 made by Ryan, CO. Iran) is closed around the arm which does not have a peripheral vein catheter and also the electrodes which detect train of four (TOF) contraction (TOF Watch SX Organon Ltd Swords, Co. Dublin Ireland) is placed in the wrist of both upper limbs over ulnar nerve and thumb to detect the contractions of adductor pollicis muscle. For sedation, patients received midazolam 0.05 milligram per kilogram of ideal body weight (mg/kg IBW) made by (EXIR, CO. Iran) and fentanyl one microgram per kilogram of ideal body weight (µg /kg IBW) made by (Caspian, CO. Iran) intravenously and after sedation of the patient, train of four (TOF) detector is calibrated. Induction of patients is started by administration of lidocaine 1/5 mg/kg IBW (made by Caspian, CO. Iran) and propofol 2 mg/kg IBW (made by Ferzenius Cabi, CO. Austria) and then Cis atracurium is administered intravenously at a dose of 0/02 mg/kg IBW, (made by Rosa Mod, CO. Iran) and the stopwatch is started immediately. When the TOF count, shows zero number of muscle contractions in one limb, this time indicates that complete block is obtained. At this time, tourniquet inflates through five seconds up to a pressure of 100 mm Hg over patient´s basic blood pressure, and the patient is intubated and the time to reach the block and the duration of the block and the recovery time in both limbs are measured separately. When the sequence of TOF remains zero, this period of time shows complete block. The time between the appearance of the first and second contraction (TOF=1 till 2) is considered as the recovery time. After recording the above parameters, the tourniquet is deflated and the anesthesia is continued with the administration of the appropriate muscle relaxant dose. Control group: In group B, up on entering the operating room, patients are non-invasively monitored for heart rate, blood pressure, and arterial blood oxygen saturation. Patients are also hydrated by a suitable peripheral vein and pre-oxygenated by a face mask. The tourniquet cuff (RS 3000 made by Ryan, CO. Iran) is closed around the arm which does not have a peripheral vein catheter and also the electrodes which detect train of four (TOF) contraction (TOF Watch SX Organon Ltd Swords, Co. Dublin Ireland) is placed in the wrist of both upper limbs over ulnar nerve and thumb to detect the contractions of adductor pollicis muscle. For sedation, patients received midazolam 0.05 milligram per kilogram of ideal body weight (mg/kg IBW) made by (EXIR, CO. Iran) and fentanyl one microgram per kilogram of ideal body weight (µg /kg IBW) made by (Caspian, CO. Iran) intravenously and after sedation of the patient, train of four (TOF) detector is calibrated. Induction of patients is started by administration of lidocaine 1/5 mg/kg IBW (made by Caspian, CO. Iran) and propofol 2 mg/kg IBW (made by Ferzenius Cabi, CO. Austria) and then tourniquet inflates through five seconds up to a pressure of 100 mm Hg over patient´s basic blood pressure and then Cis atracurium is administered intravenously at a dose of 0/02 mg/kg IBW, (made by Rosa Mod, CO. Iran) and the stopwatch is started immediately. When the TOF count, shows zero number of muscle contractions in one limb, this time indicates that complete block is obtained. At this time, the patient is intubated and the time to reach the block and the duration of the block and the recovery time in both limbs are measured separately. When the sequence of TOF remains zero, this period of time shows complete block. The time between the appearance of the first and second contraction (TOF=1 till 2) is considered as the recovery time. After recording the above parameters, the tourniquet is deflated and the anesthesia is continued with the administration of the appropriate muscle relaxant dose. Onset time of complete neuromuscular blockage. Timepoint: From administration of Cis atracurium until complete neuromuscular blockage. Method of measurement: With Chronometer. Complete neuromuscular block duration. Timepoint: The time between complete neuromuscular block until onset of recovery. Method of measurement: With Chronometer. The time of neuromuscular block recovery. Timepoint: The time between onset of recovery until complete recovery of neuromuscular block. Method of measurement: With Chronometer. Iran University of Medical Sciences Approved 2021-02-08 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)