Protocol summary
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Study aim
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Comparison of onset, duration and recovery time of neuromuscular blockage of Cis atracurium administration, before and after inflation of tourniquet in upper limb
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Design
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Two arm parallel groups randomized trial with one side blinded caregivers, over 32 patients and random allocation software are used for randomization.
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Settings and conduct
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In the operation room, after routine monitoring and access to intravenous line, Train of four monitoring (TOF) is placed on both wrist and then induction is done.
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Participants/Inclusion and exclusion criteria
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Operation is not emergency and needs general anesthesia; Body mass index is between 18 -30 and age is between 20 - 60 years old.
Volunteers should not have any history of liver; kidney; severe cardiopulmonary and known neuromuscular disease. They also should not have any vascular disease such as emboly and vascular surgery.
Absence of Sickle cell anemia; infection and any fracture or tumor of upper limbs; increased intracranial pressure; acidosis; addiction; any operation of upper limbs; neuromuscular monitoring and use of any drugs that interfere with neuromuscular function are another exclusion criteria.
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Intervention groups
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Induction starts by injection of 1.5 milligram per kilogram (mg/kg) Lidocaine, Propofol 2 mg/kg and Cis atracurium 0.2 mg/kg in the group A and immediately chronometer start measuring the time. When the Train of four monitoring (TOF), shows complete neuromuscular blockage, the time is recorded and the Tourniquet is inflated up to 100 Mm of mercury (mm hg) above the patient's systolic blood pressure and patient is intubated. Group B receive the same protocol, but only the inflation time of the tourniquet is before administration of Cis atracurium.
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Main outcome variables
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Comparison of onset, duration and recovery time of neuromuscular blockage due to administration of Cis atracurium before and after inflation of tourniquet.
General information
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Reason for update
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contradiction with proposal
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151107024909N11
Registration date:
2021-10-09, 1400/07/17
Registration timing:
registered_while_recruiting
Last update:
2023-01-12, 1401/10/22
Update count:
1
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Registration date
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2021-10-09, 1400/07/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-23, 1400/07/01
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Expected recruitment end date
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2022-11-22, 1401/09/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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Cis atracurium and Tourniquet
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Operation is elective
Operation needs general anesthesia
Body mass index is between 18 -30
Age is between 20 - 60 years
Exclusion criteria:
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
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Age
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From 20 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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No information will be provided to clinical caregivers, about which group receive the drug before or after inflation of tourniquet.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-08, 1399/11/20
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Ethics committee reference number
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IR.IUMS.FMD.REC.1399.632
Health conditions studied
1
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Description of health condition studied
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Cis atracurium
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Onset time of complete neuromuscular blockage.
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Timepoint
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From administration of Cis atracurium until complete neuromuscular blockage.
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Method of measurement
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With Chronometer
2
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Description
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Complete neuromuscular block duration.
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Timepoint
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The time between complete neuromuscular block until onset of recovery.
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Method of measurement
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With Chronometer
3
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Description
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The time of neuromuscular block recovery.
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Timepoint
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The time between onset of recovery until complete recovery of neuromuscular block.
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Method of measurement
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With Chronometer
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available