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.
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
32
24
3224
empty
contradiction with proposal
contradiction with proposal
empty
مغایرت باپروپوزال
مغایرت باپروپوزال
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Ali Javad Moosavi
Full name of responsible person - Persian: دکتر سید علی جواد موسوی
Street address - English: 5th floor, Central bulding, Iran University of Medical Sciences, Hemmat Highway
Street address - Persian: اتوبان همت، دانشگاه علوم پزشکی ایران، ساختمان مرکزی، طبقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2504
Fax: +98 21 8670 2503
Email: research-m@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Seyed Abbas Motavalian
Full name of responsible person - Persian: دکتر سید عباس متولیان
Street address - English: 5th floor, Central bulding, Iran University of Medical Sciences, Hemmat Highway
Street address - Persian: اتوبان همت، دانشگاه علوم پزشکی ایران، ساختمان مرکزی، طبقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 2504
Fax: +98 21 8862 2307
Email: motevalian.a@iums.ac.i
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Seyed Ali Javad MoosaviAbbas Motavalian Full name of responsible person - Persian: دکتر سید علی جواد موسویعباس متولیان Street address - English: 5th floor, Central bulding, Iran University of Medical Sciences, Hemmat Highway Street address - Persian: اتوبان همت، دانشگاه علوم پزشکی ایران، ساختمان مرکزی، طبقه 5 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8670 2504 Fax: +98 21 8670 25038862 2307 Email: research-mmotevalian.a@iums.ac.iriums.ac.i Web page address:
Protocol summary
Study aim
Comparison of onset, duration and recovery time of neuromuscular blockage of Cis atracurium administration, before and after inflation of tourniquet in upper limb
Design
Two arm parallel groups randomized trial with one side blinded caregivers, over 32 patients and random allocation software are used for randomization.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Comparison of onset, duration and recovery time of neuromuscular blockage due to administration of Cis atracurium before and after inflation of tourniquet.
General information
Reason for update
contradiction with proposal
Acronym
IRCT registration information
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
Registration date
2021-10-09, 1400/07/17
Registrant information
Name
Faranak Rokhtabnak
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6267
Email address
rolhtabnak.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Cis atracurium and Tourniquet
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
No information will be provided to clinical caregivers, about which group receive the drug before or after inflation of tourniquet.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1593748711
Approval date
2021-02-08, 1399/11/20
Ethics committee reference number
IR.IUMS.FMD.REC.1399.632
Health conditions studied
1
Description of health condition studied
Cis atracurium
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Onset time of complete neuromuscular blockage.
Timepoint
From administration of Cis atracurium until complete neuromuscular blockage.
Method of measurement
With Chronometer
2
Description
Complete neuromuscular block duration.
Timepoint
The time between complete neuromuscular block until onset of recovery.
Method of measurement
With Chronometer
3
Description
The time of neuromuscular block recovery.
Timepoint
The time between onset of recovery until complete recovery of neuromuscular block.
Method of measurement
With Chronometer
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Faranak Rokhtabnak
Street address
Firoozgar Hospital, Beh Afarin St., Karim Khan St. Valiasr Square,
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
rkhtbnk@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavalian
Street address
5th floor, Central bulding, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Fax
+98 21 8862 2307
Email
motevalian.a@iums.ac.i
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeed aghakhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Firozgar Hospital, Behafarin St. Karimkhan Av.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8894 6267
Fax
+98 21 8894 2622
Email
aghakhani.said@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Faranak Rokhtabnak
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Firozgar Hospital, Behafarin St. Karimkhan Av.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8894 6267
Fax
+98 21 8894 2622
Email
rolhtabnak.f@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Saeed aghakhani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Firozgar Hospital, Behafarin St. Karimkhan Av.
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8894 6267
Fax
+98 21 8894 2622
Email
aghakhani.said@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available